www.wfh.org
Volume 3, Number 3 September 2004 manufacturing of plasma products in their Helsinki plant and to enter into an agreement with Sanquin for the manufacture and supply to the Finnish market of plasma derivatives to be made from plasma collected in Finland. Both Sanquin and the Finnish Red Cross Blood Transfusion Service are not-for-profit organizations that provide the blood supply in their respective countries. The two organizations have already cooperated in the area of plasma derivatives. http://www.sanquin.nl/sanquin-eng/sqn_news.nsf/
UK vCJD announcement
On September 21, 2004, health authorities in the United Kingdom (U.K.) have informed many people with hemophilia and other congenital bleeding disorders that they are considered “at-risk” for variant CreutzfeldtJakob disease (vCJD). This risk comes from using clotting factor concentrates manufactured in the U.K. between 1980 and 1998 that were contaminated by plasma from donors who later died of vCJD, or which may possibly have been contaminated by donors who are still asymptomatic. To view the WFH TSE Task Force bulletin on these developments, please click here. http://www.wfh.org/ ShowDoc.asp?Rubrique=30&Document=37
Deadline approaches for Essential Medicines campaign
The WFH is campaigning to keep plasma-derived factor VIII and factor IX concentrates on the World Health Organization (WHO) list of Essential Medicines. The WHO plans to remove the products from the list at a meeting in March 2005. Governments refer to WHO recommendations when making decisions on health spending. The Model List of Essential Drugs contains 316 individual drugs treatments for the infectious and chronic diseases that affect the world's population. Removing clotting factor concentrates from this list sends a dangerous message: that these medicines are not essential, opening the door for governments to refuse to purchase them. The WFH is asking the hemophilia community to become active in this campaign to keep clotting factor concentrates on the WHO Essential Medicines List. Relevant comments submitted to the WHO from clinicians, researchers, patient organizations, and other experts, will make the case for retention of these products stronger. The WFH has prepared a submission to WHO as part of efforts to keep hemophilia treatment products on the list for the following reasons: • Simple laboratory tests are adequate to make a proper diagnosis of clotting factor levels. Hemophilia Treatment Centers have been established all over the world with healthcare
Recombinant in Australia
The federal government in Australia has agreed to fund a safer blood-clotting treatment, after years of lobbying from people with hemophilia infected with hepatitis C. More than 80 per cent of people with hemophilia contracted hepatitis C in the 1980s because of inadequate screening of blood products. A senate inquiry recommended in June that recombinant factor VIII be made available to people with hemophilia. State governments had indicated a willingness to fund the treatment on the condition that the federal government also contributed. The product will be available from October, at a cost of $80.7 million. Australia is one of the last Western nations to switch to recombinants. http://www.haemophilia.org.au/news/index.php?id=60 http://www.theage.com.au/articles/2004/08/31/1093938920109. html?oneclick=true
Sanquin to custom fractionate for Finnish BTS
In August the Sanquin Blood Supply Foundation (Sanquin) of the Netherlands and the Finnish Red Cross Blood Transfusion Service (FBTS) agreed to expand their cooperation on the development and production of medicinal products derived from human plasma. The Finnish Red Cross has decided to discontinue
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SAFETY AND SUPPLY NEWS
VOLUME 3, NUMBER 3 SEPTEMBER 2004 discover the true extent of its AIDS epidemic, local officials said, according to China Daily. The survey, which began on July 26, will poll over one million people in 18 cities and 35 counties in the province believed to have sold their blood at unsanitary blood stations. The survey will measure how many people in the province are currently suffering from AIDS, how many are carrying the HIV virus, and how many people donated blood for money before 1995. The Henan provincial government has so far documented 21,703 HIV carriers who were infected after selling blood at illegal and unsanitary blood stations in the 1990s. http://news.xinhuanet.com/english/200409/13/content_1973695.htm
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personnel trained in the delivery of treatment for hemophilia. Factor VIII and IX have a documented record of efficacy and are life-saving in many clinical situations. Viral-inactivated concentrates are safe while dependence on blood bank products alone in the developing world will increase the risk of viral transmissions to persons with hemophilia. Use of factor concentrates, purchased at an affordable cost, can allow for more efficacious therapy with a safer product which will increase survival rates, decrease joint damage, increase functional independence, and minimize risk of death or injury from transfusion-transmitted viruses. Hemophilia does not fit all of the criteria for a rare disease. Governments rely on WHO recommendations. Therefore, if these drugs remain on the list, this will allow national hemophilia organizations and the WFH to work to ensure that government health departments make some provision in their budget for hemophilia treatment. Retention of the products on the essential medicines list will enable governments to put in place national hemophilia programs. The expertise of the medical team brought together and augmented by such a program can be used within the country to improve treatment for other bleeding and thrombotic disorders and provide a model for the effective treatment of genetic disease.
Avigen shuts down gene therapy trial
Avigen announced that it has made a decision to discontinue its current Phase I trial for Coagulin-B and shift resources into product candidates that more closely align with the company’s new mission, in which it will expand and pursue its research and development efforts on serious and life-threatening neurological disorders, including Parkinson's disease and chronic neuropathic pain. The company claims to have every intention of preserving the large investment it has made in gene therapy for hemophilia, and is exploring with Bayer HealthCare ways to preserve the value in know-how, manufacturing, intellectual property, and clinical expertise with the hope that future hemophilia trials will be possible. http://www.avigen.com/coinfo/press_releases/2004/2004_Avig en_Realign_Prod_Dev_052704.htm
Please submit your comments to the WHO before October 31, 2004, at: The Secretary of the Expert Committee on the Selection and Use of Essential Medicines Policy, Access and Rational Use Essential Drugs and Medicines Policy World Health Organization 20 Avenue Appia CH-1211 Geneva 27 hogerzeilh@who.int http://www.who.int/medicines/organization/par/edl/expcom14 /expcom05agenda.shtml http://www.who.int/medicines/organization/par/edl/expcom14 /factorIX&VIII/factorIX&VIII.shtml
Acquired hemophilia A may be associated with clopidogrel
Acquired hemophilia A may be associated with clopidogrel, a treatment for peripheral vascular disease, hematologists from the University Hospital of Wales reported this month in a letter to the British Medical Journal (8/7/04). The physicians described two women aged 70 and 67 who presented with a history of excessive bruising and soft tissue bleeding two to three months after starting clopidogrel (Plavix; Bristol-Myers Squibb, Sanofi-Synthelabo) for peripheral vascular disease. Citation: Haj M et al. Acquired haemophilia A may be associated with clopidogrel. BMJ 2004;323. http://bmj.bmjjournals.com/
China surveys AIDS in Henan province
The Chinese province worst hit by AIDS, Henan, has initiated a survey of blood buying stations in an effort to
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SAFETY AND SUPPLY NEWS
VOLUME 3, NUMBER 3 SEPTEMBER 2004 56 th Annual Meeting of the National Hemophilia Foundation November 4-6, 2004 – Dallas, Texas, U.S.A. EBA/EPFA International Blood and Plasma Conference 2004 November 23-24, 2004 - Amsterdam, The Netherlands 46th Annual Meeting of the American Society of Hematology December 4-7, 2004 – San Diego, California, U.S.A.
Factor VII from fish
Researchers have already made factor VII from genetically modified tilapia, a freshwater fish farmed for food. The research is being carried out by the University of Southampton in the U.K. and US experts, the New Scientist reports. Factor VII is already produced using hamster cells but the cost of a single injection can be as high as £6,000. It is used to treat a rare form of hemophilia, sometimes known as Alexander's disease, and for people with the more common hemophilia A and B who reject traditional forms of treatment. Professor Norman Maclean of the University of Southampton, who led the research, told BBC News Online he was hoping to produce the protein for about a tenth of the current price. http://news.bbc.co.uk/1/hi/health/3638200.stm http://www.newscientist.com/news/news.jsp?id=ns99996367
Safety and Supply News
Published six times a year by the World Federation of Hemophilia. Available on the web at www.wfh.org. Next issue: November 2004 Editorial Board: Gordon Clarke (Northern Ireland) Albert Farrugia, PhD (Australia) Paul Giangrande, MD (U.K.) Brian O’Mahony (Ireland) Mark Skinner (U.S.A.) Editor: Mark Brooker, WFH To subscribe or unsubscribe to the WFH Safety and Supply News, please send your name and email address to lroy@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. Sally Crudder (U.S.A.) Miklos Fulop WFH (Canada) Bill Mindell (Canada) David Page (Canada) Alok Srivastava, MD (India)
Upcoming Events
National Hemophilia Foundation Gene Therapy Workshop September 30-October 1, 2004 - Philadelphia, PA, U.S.A. FDA Transmissible Spongiform Encephalopathies Advisory Committee October 14, 2004 - Maryland, U.S.A. XXVI International Congress of the World Federation of Hemophilia October 17-21 2004 – Bangkok, Thailand FDA Blood Products Advisory Committee October 21 - 22, 2004 - Maryland, U.S.A.
Published by the World Federation of Hemophilia 1425 René Lévesque Blvd West, Suite 1010, Montréal, QC, H3G 1T7, CANADA Tel: (514) 875-7944 Fax: (514) 875-8916 E-mail: wfh@wfh.org Internet site: http://www.wfh.org