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Affymax, Inc. (AFFY) Message Board

  • sonay10 sonay10 Nov 22, 2013 12:11 AM Flag

    Interesting Article I came across in Fresenius Part 1

    Timeline Breakdown of Fresenius Recall of Dialysis Drugs

    October 22nd, 2012
    Fresenius Medical Care, the German-based company responsible for treating over one third of American dialysis patients, is under scrutiny after information came to light linking their dialysis products GranuFlo and NaturaLyte to an increased risk of cardiac arrest. More troubling than the up to six-fold increase in risk of cardiac arrest over competing products is that Fresenius appears to have hid the information from the public, as evidenced by an internal memo that was released in November 2011. The memo, titled “Dialysate Bicarbonate, Alkalosis and Patient Safety,” was distributed to doctors operating in Fresenius-owned medical care centers in the United States, and warned that their products could be linked to an increased risk of patients dying through sudden cardiac arrest. It wasn’t until the memo was anonymously leaked in March of 2012 that the problem became public knowledge.

    Of particular import in a case such as this are the dates in which the situation unfolded, e.g., there was over a four months between the date of the initial memo and the release of the leaked version. Therefore, to help make the case clearer, we have outlined the most crucial developments in the case in the timeline below.

    January 1st – December 31st, 2010 – First Information Concerning Risks Emerges

    Research carried out by Fresenius Medical Care (FMC) discovers that 941 patients from 667 facilities suffered from cardiopulmonary arrest. This figure is over six times higher than that of competing products.

    Sentiment: Hold

 
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