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50 Vox Sanguinis (2003) 85, 50–51 LETTER © 2003 Blackwell Publishing Blackwell Publishing Ltd. Oxford, UK VOX Vox Sanguinis 1423-0410 2003 Blackwell Publishing Ltd 85 Letter to the Editor Letter Letter LETTER Author’s reply C. L. van der Poel, 1 E. Seifried 2 & W. Schaasberg 3 1 Sanquin Blood Supply, Medical Affairs, Amsterdam, the Netherlands 2 Red Cross Blood Donor Service, Frankfurt, Germany 3 Statistics Netherlands, Voorburg, the Netherlands Drs Offergeld and Burger stress the present high safety of blood components and plasma products. This is not disputed in our paper. We acknowledged that ‘the preparation, purifi- cation and viral inactivation procedures employed in the production of derivatives of pooled human plasma may render the difference between the safety of paid and unpaid donors for plasma products irrelevant’ [1]. Mr Bult cites a statement about the safety of plasma products by EMEA, a statement however, that continues with: ‘The question of whether or not non-remuneration is important for the safety of blood and blood components for transfusion is a separate issue outside the scope of this document.’ [2] An assessment on the reasons why unpaid donors are safer than paid ones was not the scope of our review, the reader is referred to other papers such as one by Sanchez which found that donors attracted by cash were 60% more likely to have a risk for transfusion-transmissible infections [3]. As for the methodology of our paper, it was never intended as a meta-analysis, and the raw data were not pooled. A similar analysis could address whether tomatoes over time are relatively more expensive than potatoes, without adressing price mechanisms and different currencies within comparisons. We merely question a statement by the European Commission [4], apparently supported by Mr Bult, that the difference in risk between paid donors and unpaid donors is an issue of the past only [4]. This statement occurred in the light of a draft Directive on blood components, the safety of which is related to the window period, and also the infectious disease incidence among the donors [5]. We can only conclude that the rela- tive risks in the published literature do not support that statement. Offergeld and Burger cite a recent review as an example of paid donors with a lower infectious disease marker rate [6]. However, comparisons presented by Strauss were earlier criticized by Fiedler as being of flawed methodology [7]. In response, Strauss later presents additional information. Unfortunately the comments by Fiedler in 1995 were not taken into account by Strauss in his 2001 paper [6]. The reported paid cytapheresis donors donated about five times more often per year, i.e. the incidence in paid donors would be five times higher than suggested from the presentation of the data [6]. In our paper, we addressed the limitations of the data sets, and by review one cannot escape the impression that the difference between unpaid and paid donors may have been larger if bias could have been controlled for. Given the limitations of other data sets, it seems fair to include Srauss’s findings in our assessment. Bult’s vision on arthropod-borne viruses (such as West Nile Virus) as compared to blood-borne viruses (such as Hepatitis C Virus) is interesting. Blood-borne infections by definition are predominantly transmitted by blood–blood contact, and such viruses are more frequent among drug users [8]. Indeed, an increased incidence among drug users is not likely for agents that are predominantly transmitted by other routes, such as vCJD. It remains to be seen what the predominant routes of infection are for emerging small DNA viruses [9,10]. Bult refers to tables from WHO, reporting 0–5 AIDS cases associated with transfusion pro annum in the Netherlands [11]. These data have some caveats, mentioned in the same table [11]. They represent HIV infections in the past, and although indeed all blood and plasma donors in the Nether- lands are non-remunerated, not all plasma products transfused in the past were from Dutch donors [12]. Questioned by Offergeld and Burger about the remunera- tion of donors in relation to the German NAT data, we may refer to Legler mentioning 52 DM in the methods, and comments by Roth [13,14]. Roth takes into account that the German unpaid donors may have been more often donors from rural areas with lower incidence rates, and the possibility of geographical bias was addressed in our paper. As stated by Offergeld and Burger, a nationwide surveillance of relevant infections has been established in Germany. It would not be too difficult to compare the infectious disease marker rates of the blood collection centres in the city areas for both the paid and unpaid blood donors, or reimbursing vs. non-reimbursing systems. A detailed epidemiological analysis of the German data is indeed welcomed, the independence of which can easily be adressed by publication in a peer-reviewed inter- national scientific journal. References 1 Van der Poel CL, Seifried E, Shaasberg WP: Paying for blood donations: still a risk? Vox Sanguinis 2002; 83:285–293 2 CPMP: Position Statement. Non-Remunerated and Remunerated Donors: Safety and Supply of Plasma Derived Medicinal Products 30th May 2002. EMEA/CPMP/BWP, /1818/02/Final.

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50

Vox Sanguinis

(2003)

85

, 50–51

LETTER

©

2003 Blackwell Publishing

Blackwell Publishing Ltd.Oxford, UKVOXVox Sanguinis1423-04102003 Blackwell Publishing Ltd85Letter to the EditorLetterLetterLETTER

Author’s reply

C. L. van der Poel,

1

E. Seifried

2

& W. Schaasberg

3

1

Sanquin Blood Supply, Medical Affairs, Amsterdam, the Netherlands

2

Red Cross Blood Donor Service, Frankfurt, Germany

3

Statistics Netherlands, Voorburg, the Netherlands

Drs Offergeld and Burger stress the present high safety ofblood components and plasma products. This is not disputedin our paper. We acknowledged that ‘the preparation, purifi-cation and viral inactivation procedures employed in theproduction of derivatives of pooled human plasma mayrender the difference between the safety of paid and unpaiddonors for plasma products irrelevant’ [1]. Mr Bult cites astatement about the safety of plasma products by EMEA, astatement however, that continues with: ‘The question ofwhether or not non-remuneration is important for the safetyof blood and blood components for transfusion is a separateissue outside the scope of this document.’ [2]

An assessment on the reasons why unpaid donors aresafer than paid ones was not the scope of our review, thereader is referred to other papers such as one by Sanchezwhich found that donors attracted by cash were 60% morelikely to have a risk for transfusion-transmissible infections[3]. As for the methodology of our paper, it was neverintended as a meta-analysis, and the raw data were notpooled. A similar analysis could address whether tomatoesover time are relatively more expensive than potatoes,without adressing price mechanisms and different currencieswithin comparisons. We merely question a statement bythe European Commission [4], apparently supported byMr Bult, that the difference in risk between paid donorsand unpaid donors is an issue of the past only [4]. Thisstatement occurred in the light of a draft Directive onblood components, the safety of which is related to thewindow period, and also the infectious disease incidenceamong the donors [5]. We can only conclude that the rela-tive risks in the published literature do not support thatstatement.

Offergeld and Burger cite a recent review as an exampleof paid donors with a lower infectious disease marker rate[6]. However, comparisons presented by Strauss were earliercriticized by Fiedler as being of flawed methodology [7].In response, Strauss later presents additional information.Unfortunately the comments by Fiedler in 1995 were nottaken into account by Strauss in his 2001 paper [6]. Thereported paid cytapheresis donors donated about five times

more often per year, i.e. the

incidence

in paid donors wouldbe five times higher than suggested from the presentation ofthe data [6]. In our paper, we addressed the limitations of thedata sets, and by review one cannot escape the impressionthat the difference between unpaid and paid donors mayhave been larger if bias could have been controlled for. Giventhe limitations of other data sets, it seems fair to includeSrauss’s findings in our assessment.

Bult’s vision on arthropod-borne viruses (such as West NileVirus) as compared to blood-borne viruses (such as HepatitisC Virus) is interesting. Blood-borne infections by definitionare predominantly transmitted by blood–blood contact, andsuch viruses are more frequent among drug users [8]. Indeed,an increased incidence among drug users is not likely foragents that are predominantly transmitted by other routes,such as vCJD. It remains to be seen what the predominantroutes of infection are for emerging small DNA viruses [9,10].Bult refers to tables from WHO, reporting 0–5 AIDS casesassociated with transfusion pro annum in the Netherlands[11]. These data have some caveats, mentioned in the sametable [11]. They represent HIV infections in the past, andalthough indeed all blood and plasma donors in the Nether-lands are non-remunerated, not all plasma products transfusedin the past were from Dutch donors [12].

Questioned by Offergeld and Burger about the remunera-tion of donors in relation to the German NAT data, we mayrefer to Legler mentioning 52 DM in the methods, andcomments by Roth [13,14]. Roth takes into account that theGerman unpaid donors may have been more often donorsfrom rural areas with lower incidence rates, and the possibilityof geographical bias was addressed in our paper. As stated byOffergeld and Burger, a nationwide surveillance of relevantinfections has been established in Germany. It would not betoo difficult to compare the infectious disease marker rates ofthe blood collection centres in the city areas for both the paidand unpaid blood donors, or reimbursing vs. non-reimbursingsystems. A detailed epidemiological analysis of the Germandata is indeed welcomed, the independence of which caneasily be adressed by publication in a peer-reviewed inter-national scientific journal.

References

1 Van der Poel CL, Seifried E, Shaasberg WP: Paying for blooddonations: still a risk?

Vox Sanguinis

2002;

83

:285–2932 CPMP: Position Statement. Non-Remunerated and Remunerated

Donors: Safety and Supply of Plasma Derived MedicinalProducts 30th May 2002. EMEA/CPMP/BWP, /1818/02/Final.

Page 2: Author's reply

©

2003 Blackwell Publishing Ltd.

Vox Sanguinis

(2003)

85

, 50–51

Letter

51

3 Sanchez AM, Ameti DI, Schreiber GB, Thomson RA, Lo A,Bethel J, Williams AE, Retrovirus Epidemiology Donor Study:The potential impact of incentives on future blood donationbehaviour.

Transfusion

2001;

41

:172–1784 Commission Online:

Press Release Commissioner Byrne November15th 2001.

http://www.europa.eu.International/rapidstart/cgi/guesten.ksh?, p. _action.gettxt=gt…/374|0|RAPID & lg=EN.pdf

5 Schreiber GB, Busch MP, Kleinman SH, Korelitz JJ: The risk oftransfusion transmitted viral infections. The Retrovirus Epide-miology Study.

N Engl J Med

1996;

334

:1685–16906 Strauss RG: Blood donations, safety and incentives.

Transfusion

2001;

41

:165–1677 Fiedler H: How can the safety of different types of donors be

compared?

Transfusion

1995;

35

:179–1808 Van der Poel CL, Ebeling F: Hepatitis C virus: epidemiology,

transmission and prevention. In: Reesink HW, ed.

Hepatitis CVirus. Current Studies in Hematology and Blood Transfusion

.Basel: Karger 1998:208–223

9 Schroter M, Laufs R, Zollner B, Knodler B, Schafer P, Sterneck M,Fischer L, Feucht HH: Prevalence of SENV-H viremia amonghealthy subjects and individuals at risk for parenterallytransmitted diseases in Germany.

J Viral Hepat

2002;

9

:455–259

10 Thom K, Morrison C, Lewis Simmonds P: Distribution of TT virus

(TTV), TTV-like minivirus and related viruses in humans andnonhuman primates.

Virology

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:324–33311 UNAIDS/WHO Working Group on Global HIV/AIDS: WHO

Epidemiological Fact Sheet on HIV/AIDS and Sexually Trans-mitted Infections. 2002 Update: http://www.who.int/emc-hiv/fact_sheets/pdf/Netherlands_EN.pdf

12 Mauser-Bunschoten EP: Complications in hemophilia care.Thesis, University Utrecht, 1995

13 Legler TJ, Riggert J, Simson G, Wolf C, Humpe A, Munzel U,Uy A, Kohler M, Heermann KH: Testing of individual blooddonations for HCV RNA reduces the residual risk of transfusion-transmitted HCV infection.

Transfusion

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:1192–119714 Roth WK, Seifried E: Reducing the residual riks of transfusion-

transmitted viruses: mini-pool or single-donation NAT?

Transfusion

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:845–846

Received: 2 April 2003,accepted: 8 April 2003

C. L. van der PoelSanquin Blood Supply Foundation, Medical Affairs,Plesmanlaan 1251066 CX Amsterdam, the NetherlandsE-mail: [email protected]