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Affymax, Inc. Message Board

  • tripoley2002 tripoley2002 Oct 21, 2013 7:20 AM Flag

    I posted this on Seeking Alpha but it likely will get buried over there

    Under the title: "Affymax Likely Worthless: Omontys Kills At Least 9x More People Than Epogen" I posted this:

    Christopher Raymond's analysis is flawed. He used adverse events listed as "death", "hypersensitivity" and "anaphylactic reaction" with events of 60, 50 and 10 respectively. These numbers are correct but the FDA uses medDRA preferred terms to report adverse events in order to standardize them. Omontys DID NOT list any adverse events as "death" in their 150 FAERS reports although they did list one event as "sudden death". "Death" and "sudden death" would both be classified under the adverse event category of "fatal outcomes". Epogen had 66 adverse events which would be under the "fatal outcome" category from 2004 to 2012. Using the "estimated patients per year" as above (which I have a problem with because it tells you nothing about the primary event rate) and the "fatal outcomes" category would give a rate of 0.00298% (66/2.21M) for Epogen and 0.004% (4/25K) for Omontys.

    Procrit (Jaansen branded Epogen) had 318 adverse events listed as "death" and 319 adverse events categorized as "fatal outcomes" from 2004 to 2012. I can't find any data regarding the number of patients who were on Procrit.

    Reviewing the 150 Omontys FAERS reports, there were 20 events listed as "hypersensitivity" (0.08%), 8 as "anaphylactic reaction" (0.032%), 4 as "drug hypersensitivity" (0.016%) and 1 as "anaphylactic shock" (0.004%). I will add that Epogen also had 14 events listed as "drug hypersensitivity" (0.00063%). Omontys had one outcome as DE/death from "hypersensitivity" and one from "anaphylactic shock". The "hypersensitivity" case also listed "ST segment abnormal" suggesting a cardiovascular event.
    These FAERS reports are useful in spotting trends, but each serious case needs to be investigated on an individual basis. Correlation does not imply causation.

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