Special Bulletin: Pacritinib return? (Details here.)
Melanoma: We’re all too familiar with the effects of cancer but until now we had little understanding of its beginnings. A view of the genetic fate of a cell, as it converts to a malignant state. (Full story here.)
Pacritinib: Another JAK2 inhibitor crashes at the end of a Phase III clinical trial. What does it mean for MPN patients? (TSR here.)
Pacritinib: Four patients…abandoned after the crash. Here’s what it feels like.(Short stories.)
The pacritinib affair: Screwed again. Only this time the guys in the black hats might be the Feds. “We need a T-shirt that says ‘MPN Lives Matter.’ Forget the T-shirt, we need a mob to stop traffic and shout it out at the entrance to the FDA, at the doors of Big Pharma “ (Read it Here.)
This is my wife, Karen:
On Valentine’s Day she was diagnosed with leiomyosarcoma. Seven months later, she died. Compassionate doctors enrolled her in an NIH clinical trial. It helped kill her.
(What we don’t know about Clinical Trials can kill us. Story here. )
In the current MPN Quarterly Journal issue: “Looking forward: Novel therapeutic approaches in chronic and advanced phases of myelofibrosis,” by John Mascarenhas. The complete Hematology 2015 paper (Here.)
Next week, February 25th, Dr. Robyn Scherber, our favorite MPN fatigue guru, will be on a slate of MPN specialists appearing at the MPN Advocacy and Education meeting in Washington,DC. For details of that meeting and the March meeting in San Mateo, go here.
Just Updated: The New List of Patient-Recommended Hematologists –
The MPNclinics – 302 answers to 141 Patient questions… with Index
The MPN Genetics Network .. Report on CREATE
The Catalog of MPNforum Articles. ..
Tell your story, express yourself, share your experience in your MPN magazine. You can add your comments to MPNforum articles, list your Blog, or write an article. (We’ll even help you get started.)…Letter to the Editor
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Comments on: "March, 2016" (1)
The pacritinib/clinical trial stories need two end-notes.
The main point: Pacritinib has been tested clinically for more than five years without showing sign of toxicity. Papers attesting to its safety and effectiveness were presented by leading MPN hematologists/scientists at both ASCO and ASH just months ago. Even if FDA suspected possible toxicity based on PERSIST2 confirming PERSIST1 mortality data, there was no apparent reason to abruptly terminate the trial and remove pacritinib from trial patients who were deriving benefit over more than 6 months This action, triggering the well documented symptom rebound effect of sudden cessation of a JAK inhibitor, has caused innocent patients pain and distress with inevitable health impacts. The FDA’s lack of response to concerns and questions is consistent with the Agency’s position on patients’ right to know.
There is a technical issue as well. We have outlined the argument for possible increased mortality on the pacritinib arm due to cross-over options. A concern over confusion of data due to crossover was raised by the Independent Data Monitoring Committee itself as reported here and in a CTI BioPharma press release.
We cited an example of a patient crossing over from BAT to the pacritinib arm, dying, and then being counted as a pacritinib death in subsequent data analysis. This is likely not accurate. There are various ways to handle crossover on trials, the most common being Intention to Treat wherein patients remain associated with the arm in which they entered the trial regardless of crossover. Other means of treating crossover – Per Protocol and As Treated, for example – derive different results. We have no way of knowing either what the actual numbers are or how they were accounted for in data analysis. — ZS