WFH statement on possible swine flu pandemic
April 29, 2009 – Health authorities around the world are warning about the risk of “swine flu,” a form of influenza virus. Although this potential pandemic is cause for general concern, the virus in question poses no threat to the safety of plasma-derived medicinal products such as clotting factor concentrates. More
Volume 8, Number 1
Signs of variant Creutzfeldt-Jakob disease in a patient with hemophilia
On February 16, 2009 the WFH reported that Health authorities in the United Kingdom have announced that a man with hemophilia was found at post mortem examination to have evidence of infection with the agent causing variant Creutzfeldt-Jakob disease (vCJD). The man died of unrelated causes and never showed symptoms of vCJD. This is the first time that a person with hemophilia has been found to have any evidence of vCJD infection and it is likely that the source of the infection was clotting factor concentrate used in the 1990s. The WFH will continue to follow this case closely, for more information and links to other sites, visit our website. http://www.wfh.org
5th Spanish vCJD case
Authorities have confirmed the fifth case of clinical vCJD in Spain. It is not known if the patient was a blood donor. More than 200 people have died from vCJD, the majority in the UK. http://www.promedmail.org
French HCV compensation
The French parliament has voted into law a new process for the compensation of victims of hepatitis C (HCV) infection from blood products. This will be a voluntary process, patients can still choose to sue if they want. Furthermore, the infected PWH will not have to prove the product infected him, rather manufacturers will have to prove their products were not infectious. The French Hemophilia Association has been closely involved and will continue to be consulted during the implementation process. Coverage, in French, can be found on the website of the French Hemophilia Association: http://www.afh.asso.fr/
Probe of transfusion of contaminated blood in UK assigns no blame
The Archer Report on the infected blood catastrophe that hit people with hemophilia after the UK supplies became contaminated with hepatitis C and HIV says the disaster might have been averted if imports from the United States had been blocked. Lord Archer's report described the infection of thousands of people with hemophilia with HCV and HIV as "a horrific human tragedy", adding: "Subsequent events have done little to alleviate the hurt of the victims or their families." However, the report does not name the people responsible for the mistakes that caused the catastrophe. Despite a series of strong recommendations to the UK government to renegotiate a fair, direct and more substantial compensation package with survivors and their families, the UK Department of Health offered only sympathy and a promise to look at the findings. Coverage of the report can be found on the UK Haemophilia Society's website: http://www.haemophilia.org.uk
Factor concentrates manufactured in chicken eggs
New Zealand biotech company Genavia Therapeutics has purchased the rights to use technology developed by California company Origen to manufacture and market factor VIII, and possibly factors VII and IX, produced in chicken eggs. http://www.businesswire.com
Refacto AF licensed in Europe
Wyeth announced that it has received approval from the European Commission for a variation of the marketing authorization for ReFacto moroctocog alfa (Recombinant Coagulation Factor VIII), a treatment for hemophilia A. The manufacturing process for ReFacto has been modified, and the name has been changed to ReFacto AF moroctocog alfa (Recombinant Coagulation Factor VIII). The decision by the European Commission follows a positive recommendation from the Committee for Medicinal Products for Human Use on 18 December 2008. Refacto AF is called Xyntha in the US and Canada and was approved there last year. Wyeth is in the process of shifting to the new product and the original Refacto will no longer be available later this year. http://in.sys-con.com
Wyeth to merge with Pfizer
Pharmaceutical giant Pfizer announced in January its planned acquisition of recombinant clotting factor manufacturer Wyeth. The merger is subject to regulatory approval but is expected to be finalized later this year. Wyeth has stated that it plans to continue manufacturing its factor VIII and IX products. http://www.premierbiopharma.com/
Sixth WFH Global Forum
Online registration is now available for the Sixth WFH Global Forum on the Safety and Supply of Treatment Products for Bleeding Disorders, September 24 & 25, 2009 in Montreal, Canada.
WFH Global Forums address issues related to the safety and supply of treatment products for bleeding disorders, and bring together patient groups, regulators, representatives from industry and not-for-profit fractionators, as well as doctors who treat people with bleeding disorders. The theme of the 2009 Forum is "Making the Case for Clotting Factor Concentrates" and issues covered will include:
- Projected trends in plasma production and supply
- Prophylaxis models around the world
- Threats to hemophilia care in a tightening economy
- Expanding markets and other trends
- New rare factor concentrates
- The risk of variant Creutzfeldt-Jakob disease
The draft program is available from the WFH website at: http://www.wfh.org
Events
Plasma Protein Forum 2009
2-3 June 2009 – Washington, D.C., USA.
Internet: http://www.plasmaproteinforum.com
6th IABs Symposium on Advances in Transfusion Safety
6-7 July 2009 – University of Cambridge, United Kingdom
Internet: http://www.haem.cam
XXII ISTH Congress
11-17 July 2009 – Boston MA, USA
Internet: http://www.isth2009.com
Global Forum 2009
24-25 September 2009 – Montreal, Canada
Internet: http://www.wfh.org
Safety & Supply News
Published bi-monthly by the World Federation of Hemophilia.
Next issue: June 2009
Editorial Board: Claudia Black, WFH (Canada); Keith Hoots, MD (U.S.A.); Elizabeth Myles, WFH (Canada); Brian O’Mahony (Ireland); David Page (Canada), Mark Skinner (U.S.A.); Mike Soucie, PhD (U.S.A.); Alok Srivastava, MD (India); Alison Street, MD (Australia)
Editor: Mark Brooker, WFH World Federation of Hemophilia
1425 René Lévesque Blvd. West, Suite 1010
Montréal, Québec H3G 1T7 Canada
Tel.: +1 (514) 875-7944 Fax: +1 (514) 875-8916
E-mail: wfh@wfh.org
To subscribe or unsubscribe to the WFH Safety and Supply News, please send your name and email address to aryan@wfh.org.
Permission to translate and/or reprint all contents of the Safety and Supply News is granted to interested non-profit hemophilia organizations, with prior approval and appropriate acknowledgment of the WFH. Permission does not extend to reproduction, in whole or in part, for sale or use in conjunction with commercial purposes.
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