Mind-boggling! – Aftermath of Tofacitinib FDA Hearing Part 2 | Rheumatoid Arthritis Warrior

Mind-boggling! – Aftermath of Tofacitinib FDA Hearing Part 2

Tofacitinib FDA hearing aftermathAfter the FDA Arthritis Advisory Committee (AAC) hearing earlier this month for Pfizer’s new oral treatment for RA,  tofacitinib, we looked at the four distinct votes of the AAC and some of the ways the media responded to them. They ranged from serious to pitiful to laughable. But there’s more.



3 news bytes that might boggle the mind, post-tofa hearing

emaxhealth aspirin comment1) The aspirin-recommending doctor who wrote about the “rheumatoid uterus” made changes to his article as a result of comments from patients who were stunned to hear about the silliness. Within hours, uterus became arthritis. And later, any aspirin reference was removed. Although we’ve seen at least three versions of the article, it does not mention an edit or a retraction. (Click thumbnail on right to enlarge.)

rheumatoid uterus by emaxhealth
2) According to Fierce Pharma, a majority of 30 “big payers” surveyed after the AAC hearing planned to require RA patients to fail at least one TNF inhibitor such as Enbrel or Humira before paying for Pfizer’s new oral treatment. Even though the AAC only provide recommendations, and the FDA will decide tofacitinib’s fate later this year, payers’ opinions appear to have been influenced by comments made by members of the committee. “After the discussion and vote, ‘substantially more payers … said they would require failure of two anti-TNFs before allowing access to tofacitinib,’ Reimbursement Intelligence CEO Rhonda Greenapple said in a release.” I doubt most of those surveyed attended the hearing, but read excerpts and press coverage about questions asked by committee members. Some members are experts in RA or rheumatology, some are not; there is no Rheumatoid patient on the committee.
Screenshot of FP tab: Payers Throw Up-
3) A CBS report actually referred to tofacitinib as a pain medication. It’s not surprising when they refer to a systemic disease like Rheumatoid as merely arthritis. The disconnect created by the terminology has never been clearer: “If approved, tofacitinib would be the first pill for rheumatoid arthritis from a new class of pain medications called JAK inhibitors. The drugs work by interfering with enzymes that contribute to the inflammation process that causes joint pain, particularly in the hands and feet.”

Wondering about what perpetuates nonsense like that?

If you have no idea what Rheumatoid Arthritis is and see reputable websites like the Wall Street Journal refer to RA as a disorder causing arthritis in the hands and feet, it makes perfect sense to recommend aspirin as an RA treatment or refer to tofacitinib as a pain medication. Of course they look at side effects of a medication which interferes with immune function as “overkill.” They have no idea what the disease itself does to people. Or why a company like Pfizer would spend a decade developing a new treatment.

Putting aside how some patients felt to see a serious diagnosis like RA minimized yet again, there are 2 important reasons this press coverage is irresponsible, leading a doctor who does not understand modern rheumatology to recommend that people with RA try aspirin instead of tofacitinib.

  1. Therapeutic doses of aspirin were responsible for a large number of hospitalizations and deaths of RA patients over the last few decades due to the dosing required to treat the systemic inflammation of RA.
  2. The Wall Street Journal notwithstanding, RA is not equal to arthritis. RA is a systemic disease which has destructive arthritis as a significant symptom. Unfortunately, that’s only part of the story and the disease requires treatment. Read a moving article about misconceptions on RA, by someone who is not an RA patient.

CONTEST WINNERS: Winners of the Scavenger Hunt contest will EACH receive a box of 6 Trudeau kitchen tools. Winners are Summer T. and Martha R!! Entrants said they had a lot of fun and I’m happy we can give away these prizes. Let’s do another contest soon!

The tofacitinib FDA hearing as it unfolded here on rawarrior

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Kelly O'Neill

Kelly O'Neill (formerly Kelly Young) has worked about 12 years as an advocate helping patients to be better informed and have a greater voice in their healthcare. She is the author of the best-selling book Rheumatoid Arthritis Unmasked: 10 Dangers of Rheumatoid Disease. Kelly received national acknowledgement with the 2011 WebMD Health Hero award. She is the president of the Rheumatoid Patient Foundation. Through her writing and speaking, she builds a more accurate awareness of rheumatoid disease (RD) aka rheumatoid arthritis (RA) geared toward the public and medical community; creates ways to empower patients to advocate for improved diagnosis and treatment; and brings recognition and visibility to the RA patient journey. In addition to RA Warrior, she writes periodically for newsletters, magazines, and websites. There are over 60,000 connections of her highly interactive Facebook page. You can also connect with Kelly on Twitter or YouTube, or LinkedIn. She created the hashtag: #rheum. Kelly is a mother of five, longtime home-schooler, NASA enthusiast, and NFL fan. She has lived over fourteen years with unrelenting RD. See also https:/rawarrior.com/kelly-young-press/

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14 thoughts on “Mind-boggling! – Aftermath of Tofacitinib FDA Hearing Part 2

  • May 25, 2012 at 8:37 am

    The picture of the RAD patient that fails TNF inhibitor treatments is just not accurately portrayed to the public in general. Everyone thinks these treatments work for everyone. I have failed every TNF inhibitor. Our video from the RPF is the best way to get the word out that we need new treatments. Maybe when I have two electrode leads running out of the back of my head exposed, that will be the picture that shows we need more treatments because this is a deadly and debilitating disease.

    • May 25, 2012 at 9:16 am

      good point. It is advertised that way and many docs even are told that they work on everyone. I’ve had several patients tell of a doc who withdrew a diagnosis becasue of TNF failure.

      • May 26, 2012 at 4:08 pm

        How could a qualified doc remove a diagnosis because a patient did not respond to one of these treatments? TNF’s are not the tell all. It is just like swelling and the nuclear bone scan. Just because a patient does not have visible swelling does not mean they do not have RA. There have to be standards set. What we do know is that early intervention does make a difference, to walk a patient away has the potential to be devastating.

  • May 25, 2012 at 10:39 am

    re: #3. ‘Scuse me while I go bang my head against a wall.

  • May 25, 2012 at 12:52 pm

    I’m sorry… I don’t even have to read the article to know that doctor is a d’bag. 🙂

  • May 25, 2012 at 2:23 pm

    In January 2010 I found out I had colon cancer. I’m in remission after successful chemotherapy, and my oncologist says I’m supposed to wait five years from the end of my chemotherapy in September 2010 to take TNF inhibitors. It’s been a year and a half since chemo ended and my oncologist says to at least wait until three years elapse. Would someone like me still have to try and fail TNF inhibitors before being allowed to try Tofacitinib?

  • May 29, 2012 at 3:26 am

    I got excited when I read one tnf blocker, but yeah…that is probably not reality. Had side effects from humira so I don’t know if that counts as failed. Depending on vetra da test, probably enbrel next. I hope a bunch of you are okayed to try the new med. Anyone hesitant and why?

    • May 29, 2012 at 12:25 pm

      I’ve been struggling with this disease for 30 yrs. I’ve tried lots of new meds when they came on the market rapidly (mostly NSAID’s). For the past 15 yrs my personal timeline for taking new drugs is to wait 18 months after its release before trying it (same for anything for my kids). I figure that is enough time once it is released into a larger patient base for any immediate side effects to start to show up.

    • May 29, 2012 at 3:06 pm

      Whether it’s one or two tnf’s, it may depend on the payer (government or insurance). We’ll see what the FDA says in August. Side effects is different than “failed” as in non-responder, but either way, you couldn’t keep taking it, so it may count the same as in “strikes.”

      Hesitant? Yes. Because we do not know long-term effects. And we do clinical trials on RA patients who don’t have any/many co-morbidities, but most of us do actually have a few. So, it makes me hesitant. But I’ll still try it as soon as possible because I’ve had no relief & no break in “flare” (disease activity) for 6 years and would really like to be able to do a few things…

  • July 5, 2012 at 1:28 pm

    Tofacitinib as with any new medications offers promise of cure, relief and exceptional medical advancement – the deployment of the JAK enzyme modifier offers but another method to inhibit the inflammatory aspects of RA. The key word being new; this offers little insight as to population based side effects than may reflate to unintended consequences. We are unique in our DNA structures, enzymes etc., so without extensive population surveillance, seemingly minuscule signals may not be recognized pointing to poor outcomes or actual medication driven harm. Let’s remember that FDA approval means little other than the controlled testing for determination of the product being non-poisonous was passed and approved.
    Watch and wait is the key.

    • July 5, 2012 at 1:34 pm

      I agree that after approval, side effect & adverse event information will be more evident. You can read some of my views on that topic by searching Orencia on this site – there’s an article addressing how much more clear it can be after the fact and why. However, I’ll also add that about 5,000 people have taken tofa during the trials which is I believe higher than most approved drugs. Our approval process in the US seems much longer & more elaborate than it was in the past with meds we have long trusted such as tylenol.

  • December 27, 2012 at 4:38 pm

    Rheumatoid uterus!!! Oh my God in heaven. That is rich. I’m pretty sure I have that, too. I’ve got rheumatoid everything.

  • December 27, 2012 at 7:10 pm

    I’ve now been on Xeljanz for over 2 weeks now and so far, so…..good? We’ll see how this goes in the long run!!! I developed panniculitis (an immune reaction where the fatty layer under the skin becomes inflamed and painful and can ulcerate), so we moved on from Cimzia to this. I’m the first person in my whole region to be on it! Fingers crossed!

  • April 27, 2013 at 11:03 am

    Re XELJANZ which I said I have been taking for 5 months. My fatigue is gone and all my blood work is normal. HERE IS MY PROBLEM.

    IF I READ THE ABOVE CORRECTLY, they are talking about anti TNF factors. This drug was to stop the cytokines at its hub. When I had to beg my rheumatologist to do a cytokine test on me, yes beg, he was indifferent. But I begged and he did as I requested.

    There was only one question I asked him when he did not want to approve the test.

    If cytokines were not important, then why are these drug companies developing and manufacturing RA drugs that curb TNF and other cytokine levels? Does not make sense NOT to check it.

    Please read. MY TNF cytokine factors were NORMAL> BUT my IL6 (interluekin 6) was 56!

    The normal is around 3. When I showed this to my doctor, he approved Xeljanz for him. Pfizer has a great co pay system.

    I took it for six weeks and began to feel a little better. But with RA you never know. When you wake up a different pain surprise awaits! Oh where did that come from!

    Eight weeks passed. Still taking xeljanz so I asked doctor to do another Cytokine test and check my IL6 and TNF. He did reluctantly. Well two weeks ago my IL6 was 3! and my TNF normal.

    Why are they talking JUST anti tumor necrosis factors (TNF) for drugs when RA victims differ. Some may have a high TNF but I did not. It was my IL6 that many do not even know what I’m talking about. I did a lot of reading.

    With Xeljanz, as I’ve said previously, all my blood work is in normal range. Sed normal as well. I did have at one point a normal SED and I was inflamed which leads me to believe that the cytokine inflammation play a much more important part than anyone realizes. I would hate to think that people in charge are discussing a drug and not know all the aspects of it. So again, check your cytokine levels. There are four but the biggest with RA factors is IL6 and TNF.

    TNF being far more common than IL6. Many doctors don’t even know what I’m talking about either and that is another frustration.
    So here I am taking Xeljanz now for five months, going on six and I feel no fatigue, better than I’ve felt in two decades after taking Humira, Enbrel, MTX, Simponi, steroids, NSAIDS, the horrific PRED, you name it, I’ve taken it and this is the one two times a day PILL that has helped. There was some mornings I didn’t think I could make another day. I was in self pity mode but thank god I had my husband constantly telling me there were others worse than me. I have to live by that motto. No one understands except the RA victim. I so miss the things I used to do so normally, like walk up a few stairs!

    I so dreaded those infusions for I never knew what type of reaction I was going to have. It was different each time and I know I said this earlier, but when you hear of a drug like XELJANZ that STOPS THOSE DARN INFLAMMATORY CYTOKINES AT THE HUB, you sit up and take notice. I’ve been on it from nearly the day it was approved and I become so angry when I read idiotic statements from those with authority and power to change something.

    I’ve had RA for over 20 years now and I am now going for my third joint replacement because my SED rate was so high at one point, they didn’t know what to do with me. They even sent me to a hemotologist who said I had a form of leukemia and he wanted to check my bone marrow because my hemoglobin was low. White, red , you name it all the cells were way out of whack. You want to know why? IT WAS ALL BECAUSE OF MY SED RATE. NOTHING ELSE. NOTHING! I went to a trial clinic and took a drug that reduced it and I slowly went to normal a few years ago but it was TOO LATE. My joint damage was done. Even with Xeljanz I have to live with the past destruction. So, if you are in my boat, this may be the one for you, but I suggest you check your cytokine in a blood test. Read up on it. Do your homework and then see your rheumatologist and tell him what you want to do. Remember, I have a very learned rheumatologist, but even he says this is one of the strangest diseases he’s seen. For, everyone is so different and we never know what is going to strike next in our bodies, for it affects every single part of us, not just hands and fingers as some may, with neanderthal thinking, suggest. Take charge of your body now. I guess I still do not understand the European discussion panel on joint destruction It seems to be if your SED and CYTOKINES are down, the inflammation that has been eating away at your body as ceased. I can understand the side effects, but my gosh, look at the side effects on some of the infusion drugs. When I first began Humira, it was like a miracle but it only lasted a year, Enbrel did nothing. Simponi did nothing. And all this while the joint destruction continued.

    These drugs they say are all for TNF, well I did not do cytokine testing years ago. I did not know about it, perhaps my TNF WAS HIGH and HUMIRA reduced it and maybe I HAD TWO CYTOKINES THAT WERE HIGH. That is why I keep on going back to these cytokine levels in our RA bodies. There is not enough emphasis placed on their importance.



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