Granuflo powder/acid dialysate: Blame Doctors?
Despite several opportunities to right a wrong, Fresenius Medical Care (FMC) has conspicuously failed to define and clarify the potential issue and controversy surrounding its Granuflo dialysate powder acid concentrate. Judging by the content of its “Dear Doctor Letter” issued in March 2012, FMC is treating this deadly outcome as a matter of “fuzzy math” on the part of doctors. The letter implies that hundreds of doctors have simply neglected to read product labels correctly, and that those same doctors have failed to add simple figures to arrive at an accurate final product.
But how difficult would it be to add 24 units of bicarbonate with 8 units of acid from Granuflo, to get a yield of 32 units in the final solution? How did so many doctors arrive at 36 units instead of the mathematically expected 32? Did this suggestion of incompetency in math really cause the death of 941 patients from sudden cardiac arrest in FMC’s in-facility dialysis centers in 2010 alone? Or is this claim that doctors used fuzzy math just a shameless cover to hide a much greater problem? Is it a problem that Fresenius has had knowledge of since 2003 when a new formulation of Granuflo was approved for marketing?
At this juncture, it looks like the Granuflo problem arises from the complex nature of chemical compounds used as the source of acid in Granuflo dialysate. This intricate mix of compounds needs precise product disclosure by Fresenius as the manufacturer of product; but, for whatever reason, the company failed to provide that disclosure.
Since Granuflo was formulated with Sodium diacetate, it has consistently gained market share. Sodium diacetate made Granuflo more cost effective. It was cheaper to transport and store at facilities. But Granuflo’s rise in dialysis market share coincided with the number of patients dying of sudden cardiac arrest. Sodium diacetate, when mixed with certain chemicals, has properties which FMC failed to share with physicians. That is the crux of the matter.
All of this brings us back to that “Dear Doctor Letter.” It looks right now like a ruthless move by FMC calculated to further increase market share and corporate profit, behind the cover of transferring blame to dialysis doctors and other healthcare professionals.