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  • end2war end2war Apr 8, 2014 8:57 PM Flag

    Back to the Political Issues and How the Hold might be a slap on the wrist of DR Tefferi!

    Doctors Square Off in Important Battle Over Unapproved Blood Cancer Drug

    ASHEVILLE, N.C., March 28, 2014 /PRNewswire/ -- It's hard to imagine heavyweight hematologists publicly squaring off in support of an off-label blood cancer drug. And yet, today, that's exactly what happened in an "Open Letter to the MPN Community of the United States,"

    "… I am worried," said Hasselbalch, "by the reported claims by Dr. Ayalew Tefferi that interferon is no better than (hydroxyurea) and busulphan in the MPNs. If Tefferi has said so, it is problematic that a colleague, who may be aware of his great impact on the 'scientific community' and MPN-patients' care, stands up and not tells the truth…I cannot dissect or understand the reasons for his anti-IFN attitude."

    "I agree with everything [Hasselbalch] says," wrote Silver. "Recombinant interferon is the only drug used in the myeloproliferative diseases that has a physiological basis for its use… instead of the non-specific killing activity of hydroxyurea and other similar compounds."

    The Open Letter was triggered by Tefferi's remarks on interferon in a teleconference with an MPN patient group February 23 ( during which he reported on his upcoming clinical trial of a new MPN drug, Geron's Imetelstat. (Imetelstat was put on clinical hold by the FDA last week, reportedly due to problems in liver toxicity.) Tefferi, a principal investigator in many MPN drug trials, has publicly stated his lack of support for interferon as well as his opposition to an FDA approved myelofibrosis drug, Jakafi.

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    • end - I love you but you are not correct in this case. Today Dr. Tefferi stated that the FDA was only concerned about reversibility in ET because they pretty much "live forever".

    • Yes, politics I'm afraid has raised its ugly head again, and undoubtedly is a factor here. How much a factor, we probably won't ever know. More evidence of efficacy is what we need. Unlike religion, which was the other body politic we had to face in the past, arguments among scientists can be resolved by evidence.

    • end: of all possible ulterior reasons for the FDA Hold, I think that this one rates pretty close to the bottom of the list!!!

    • ....and rightfully Hasselbatch should be worried, interferon & Jak both suck. Tefferi stands behind his clinical observations and has every right to express his medical experience wrt to treating MF. Since when should the scientific community operate with a gag order? Clinical proof speaks louder than status quo.

    • That press release was written by the guy who operates the MPNforum web site. He, and a bunch of people who post on that site have been blasting Tefferi because they believe Tefferi is not offering his patients access to all potential MF treatments. They are principally upset with Tefferi over his position on pegylated interferon, as several members of the MPNforum have been treated with interferon, apparently with success, but Tefferi does not hold the treatment in high regard. Some of the stuff they’ve written is pretty close to libel in my opinion.

      • 2 Replies to ozzie_ozborne
      • What you guys are talking about Dr. Tefferi's criticism about his remarks against IFN and Jakafi in the MPN Forum, especially the forum's editor Senyak now was brought up by me several weeks ago!! None of you really bothered to pay attention then!!

      • ozzie - I agree. The MF patients I have encountered are not always the best informed and often rely on less than reliable pharmaceutical research data. Dr. Tefferi wants to insure they have the best possible treatment that actually works. However, denial reactions are tough and I have found that many dying MF patients and their families are highly emotional and are so desperate that understandably they are less than rationale and analytic, easy to manipulate with speculative "hope", and often act against their own best interests. MPNforum - that Dr. Tefferi was instrumental in forming about 2002 - is now very political. This is the reason that Dr. Tefferi will not let big pharma attend any of his patient conferences (all private grant funded). I hang out here instead of MF boards (very depressing and frustrating) because [most] investors seem to act in their own best interests. In the "long" run that is in the best for Geron and the patients - IMO.

    • Silver's political, scientific, and economic agendas in this open letter, in my opinion, are very highly suspect. It is well known he is a major researcher for Jakafi (also known as Ruxolitnib) which was funded by Incyte. Below are his studies supporting Jakafi easily found on Medline.

      " A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis. (Funded by Incyte; COMFORT-I number, NCT00952289.)."

      " Effect of ruxolitinib therapy on myelofibrosis-related symptoms and other patient-reported outcomes in COMFORT-I: a randomized, double- blind, placebo-controlled trial."

      " The clinical benefit of ruxolitinib across patient subgroups: analysis of a placebo-controlled, Phase III study in patients with Myelofibrosis"

      "Efficacy, safety and survival with ruxolitinib in patients with myelofibrosis: results of a median 2-year follow-up of COMFORT-I."

      " Ruxolitinib for myelofibrosis-an update of its clinical effects."

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