Hydrophobic PF5070: dialysis repair and sudden death in dialysis patients

Stanley Shaldon1 and Karl Martin Koch2

125 le Michelangelo 7 Avenue des Papalins Monaco 2Abteilung Nephrologie Medizinische Hochschule Hannover Hannover, Germany Email: stanley_shaldon{at}monaco377.com

Sir,

We read with interest the letter of Dr Canaud, published by NDT in July 2003 [1], replying to a letter by Drs Slavicek and Jerin [2] about the responsibility for the epidemic of sudden deaths on dialysis, which occurred in Croatia in October 2001. In their letter, Drs Slavicek and Jerin complain about the suggestion in the original expert report of Dr Canaud [3] that there was an element of responsibility for these deaths at the level of the end-user and that his subsequent apology published in September 2002 [4] was inadequate. In his most recent letter [1], Dr Canaud still appears to believe that PF5070 (the toxic substance that caused the deaths of 23 patients in Croatia) might have been removed by more adequate dialyser rinsing. In support of this belief, he states ‘At this stage of the discussion, it is also interesting to remember that several years ago, some capillary filters were extruded and filled with a glycerol solution to keep the fibres open (e.g. Amicon®, haemodiafilter). Interestingly, glycerol, a hydrophobic and insoluble compound, was completely removed by conventional rinsing procedure of the dialyser with 2 l saline.’ This statement confirms, in our opinion, his persistent bias or suspicion that end-user responsibility might have been involved in the tragic accidents in Spain and Croatia in August and October 2001, as in fact glycerol, in contrast to PF5070, is a strongly hydrophilic compound [5] that rapidly dissolves in water and consequently is completely removed by a standard 2 l saline rinse.

Finally, given the new policy of NDT on the mandatory requirement of authors to sign a ‘Conflict of Interest Declaration’, we find the absence of such a declaration curious, given that he was appointed by Baxter International, Inc. as the head of their expert panel to investigate the deaths following exposure to PF5070 in October 2001 [6]. This omission is even more surprising in view of ongoing litigation against the company concerning deaths associated with PF5070 and an outstanding FDA subpoena related to these deaths [7].

Conflict of interest statement. S. Shaldon is a consultant for Fresenius Medical Care AG Germany, Nipro Corporation, Japan, and Patton Boggs LLB Washington DC, USA. K. M. Koch declared no conflict of interest.

Notes

Editor's Note

The conflict of interest statement has been mandatory for all papers published in the September 2003 issue onwards.

References

  1. Canaud B. Reply to letter entitled ‘Liquid test and sudden death in dialysis patients’. Nephrol Dial Transplant 2003; 18: 1413–1414[Free Full Text]
  2. Slavicek J, Jerin L. Liquid test and sudden death in dialysis patients. Nephrol Dial Transplant 2003; 18: 1413
  3. Canaud B, on behalf of the European Expert Panel. Performance liquid test as a cause for sudden deaths of dialysis patients: perfluorohydrocarbon, a previously unrecognised hazard for dialysis patients. Nephrol Dial Transplant 2002; 17: 545–554[Free Full Text]
  4. Canaud B. Liquid test and sudden death in dialysis patients. Nephrol Dial Transplant 2002; 17: 1706–1707[Free Full Text]
  5. http://www.mallchem.com/msds/englishhtml/G4774.htm. Materials Safety Data Sheet MSDS Number G4774 1st November 2001 GLYCEROL
  6. http://www.baxter.com/utilities/news/releases/2001/10-15dialyzer.html
  7. http://www.clinica.co.uk. Clinica 1050 March 21 2003. Baxter reports FDA subpoena, revises expectations. PJN Publications Ltd 2003




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