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

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KB_Washington_MonumentAfter 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 Young. All rights reserved.

This entry was posted on Friday, May 25th, 2012 at 5:00 am and is filed under Reality Check. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.

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