| Posted by
Dave Cavenaugh 03-17-2009 |
WASHINGTON UPDATE |
 |
|
March, 2009 Vol. 11 No. 2
> BRITISH FIND VCJD IN OLDER MAN WITH HEMOPHILIA
The United Kingdom Health Ministry announced on February 17, 2009 that researchers had discovered evidence of variant Creutzfeldt - Jakob disease (vCJD) during a routine autopsy on an older man with hemophilia who had died of unrelated causes. Evidence of vCJD was found in the spleen. Although he had not shown the symptoms associated with vCJD, the presence of prions, thought to be the causal agent of vCJD, was clear. This is the first known confirmatory evidence of vCJD in a person with hemophilia. While there are other known vectors for contracting the disease, the medical history of the man (use of plasma-derived factor until the late 1990s) and the fact that one of the donors to the plasma pool from which the product he used was made contracted the disease shortly after donating, convinced researchers that this was the route of transmission, rather than the more widely recognized beef consumption route. For the second time in a decade, the entire British hemophilia community has been warned about the potential blood-borne transmission of vCJD through factor concentrates. They are to consider themselves at highest risk, and inform medical providers of this before receiving care. There is no treatment for vCJD itself, however, and it is universally fatal. Blood transmission of CJD and vCJD has been debated and discussed since the early 1990s. That debate became more intense and urgent following the vCJD outbreak in the mid 1990s in Great Britain from contaminated beef, leading to a number of deaths in the UK. Those deaths were clearly associated with the consumption of tainted beef. The UK outbreak raised concerns in the hemophilia community regarding the potential for blood and plasma donors who had been exposed to vCJD from beef to transmit the pathogen through their blood and/or plasma donations.
|
On February 19, COTT issued a press release, described below. On February 24, 2009, In a communication to FDA, COTT expressed its serious concern regarding the matter and requested a meeting of the Transmissible Spongiform Encephalopathy Advisory Committee (TSEAC) and asked for a review of the agency’s December 2006 risk assessment model for the blood borne transmission of CJD and variant CJD. On February 25, 2009, in reply to COTT, Dr. Jay Epstein, Director, Office of Blood Research & Review (OBRR) at FDA stated that, “We are not presently aware of any information that would substantively effect our assessment of the product risk in the US.” Dr. Epstein added, “However, we regard this case as significant and we are continuing our internal investigation.” On Wednesday March 11, 2009 COTT’s Blood Safety Working Group engaged FDA CBER on a teleconference. COTT sought to understand FDA’s view of the troubling UK discovery. The COTT Working Group, comprised of Dave Cavenaugh, Government Relations, Dr. Rich Colvin, COTT Medical Director, Chris Templin, COTT Secretary and member of the FDA TSEAC and COTT President Corey Dubin, engaged in a robust discussion with Dr. Epstein, Dr. Mark Weinstein, Associate Deputy Director for Medical Affairs, OBRR, and David Asher, Laboratory of Bacterial, Parasitic and Unconventional Agents, and Jennifer Scharpt MPH, Assistant Director for Policy and Communications, both also of OBRR. _______________ * includes updates/revisions not found in copies distributed at HFA Symposium 3/14/09
. The British case changes the questions of vCJD transmissibility through blood/blood products from the theoretical to the probable in terms of that risk no longer being hypothetical. While the risk to the end users of factor concentrates in the US remains low, this case illuminates the need for substantive funding and research to further our understanding of vCJD. COTT calls on the Obama Administration to direct Secretary of Health and the Secretary of Agriculture to coordinate their efforts to ensure USDA surveillance and monitoring of US cattle. We remain troubled by the lack of a substantive and wide-ranging surveillance program at the USDA. The policy disconnect between USDA and FDA over animal versus human health can no longer be used as a basis for inaction on this growing threat to our nation’s health. The February 17 th memorandum from the United Kingdom’s Health Protection Agency (HPA) is included as Attachment #1 to this Update. The Press Release issued by COTT (to the Associated Press, the Washington Update subscriber list, and the CJD News listserv) is included as Attachment #2. A reprint depicting how the UK hemophilia community is reacting to the way in which the National Health system is treating them in the middle of a decade of scares, is in Attachment #3. While banning of ‘downer’ cattle from the food chain (see Agencies, below) is a good first step on the road back to sound protection of the food supply and hence blood supply from mad cow, additional measures are needed. Replacing the inadequate survey plans used to date by USDA for mad cow surveillance with a rational, complete methodology, and development of compensation policies for farmers who come forward to report problem animals. At present, the farmer must pay to transport the animal and for the government’s tests; if the test is positive and the animal destroyed the compensation given falls far short of fair market value. Further, if one cow tests positive, the farmer’s entire herd may be destroyed, wiping out his and his family’s income with little or no compensation whatever. Currently, knowing these costs and risks, many farmers quietly dispose of such animals, increasing risks of transmission. . > STATE-LEVEL ISSUES . California – Soon after 5:00 am on February 19th, the California state legislature ended over 45 hours of being in session, locked in the Capitol Building until a final 2008-2010 budget was passed, more than three months after the Governor convened a special session to address a $40 billion state deficit. In the final bill, spending cuts amount to $15 billion; temporary taxes $13 billion, and new borrowing $11 billion. The spending cuts come from health care, education and entitlement programs; specifics are pending. The federal stimulus bill is expected to reduce the amount of new borrowing required by over $5 billion. Meantime, lacking a budget, state agencies have already begun requiring mandatory unpaid furloughs two days per month of their employees (for example closing all Dept. of Motor Vehicles offices in the state every other Friday), and preparing layoff notices for some 20,000 state employees. Other cost-savings measures: No Californian awaiting a tax refund from 2008 will be getting it any time soon; local governments are not receiving various expected payments from the state, and over 100 construction projects have been stalled, with several hundred more facing cancellation (jeopardizing almost 100,000 jobs). The cutbacks mirror what is going on nationwide in the commercial world, and constitute a dangerous premonition of what government as well as industry may soon be going through in many states. In April of 2008, just fewer than one-half of the states reported having budget shortfalls; in January of 2009, 47 are in this predicament. . On March 13th , however, the state’s Legislative Analyst announced that, due to the economic downturn, expected revenues were not realized, and the state once again faces a deficit, now at a level of $8 billion. . > CONGRESS . The Economic Stimulus bill passed both chambers of Congress on February 13th and was signed into law by President Obama at a solar-panel manufacturing plant (to symbolize future growth opportunities) three days later. Work on the legislation essentially began shortly after the large financial bailout bill was passed in September: One-third of a year of sinking employment, production and stock prices passed (as well as the discovery that the first bailout had been far less effective than expected) before this new, assistance, targeted toward other sectors of the economy, could be made available. Local press in the days since contained detailed accounts of the plans by local governments and others for use of the many pots of money in the bill. (The money, of course, is not available yet; Washington takes months to convert a Presidential signature into checks in the mail.) The final bill ended weeks of wrangling over how much should be tax reduction and how much direct spending. Briefly, in health care, $90 billion was allocated for shoring up the state-administered Medicaid program for low-income persons; $20 billion was included for helping those losing jobs to take advantage of COBRA (a federal provision that requires insurers to offer much-higher-cost individual insurance policies to those laid off) by providing a 65% subsidy of those costs; $2 billion will go to Community Health Centers, ¾ for renovations and technology and $500 million for direct care. $1.1 billion is also included for comparative effectiveness research, discussed in the last Update, and $1 billion for immunization and other prevention programs. . > WHITE HOUSE / ADMINISTRATION / AGENCIES . It has been widely recognized that the withdrawal of former Sen. Tom Daschle from the nomination for Secretary of the Department of Health and Human Services (DHHS) placed a serious slowdown on the new Administration’s efforts to enact health care reform. The lengthy period without nomination of a suitable replacement nominee took a real toll on the Department. For example, when the Economic Stimulus bill was being debated, the Senate bill would have provided $5 billion for prevention programs – STB, asthma, substance abuse, HIV-HCV-TB. Without DHHS advocacy, the final amount fell not just to the House figure of $3.8 billion, but to only $1.0 billion – a loss of at least one-third. . COTT is pleased with the nomination March 3rd of Ms. Kathleen Sebelius, Governor of Kansas, to the position. One of the acknowledged accomplishments in her career was, in her previous position as state Insurance Commissioner, that she denied the request from Wellpoint, the insurance giant, to convert Kansas Blue Cross from a non-profit to a for-profit subsidiary corporation. This stance was the only reversal in Wellpoint’s 14-state buy-up of Blue Cross plans. As non-profits, these plans had been for the most part good community citizens, using state funds and their own revenues to help meet the crippling need for health care for the uninsured. No longer. . On March 13th, President Obama announced a new Working Group on Food Safety, comprised primarily of USDA and FDA representatives. He also indicated that USDA will no longer permit the inclusion of ‘downer’ cattle (ones that cannot walk on their own, perhaps due to Mad Cow disease) in the food chain. He also announced the appointment of Dr. Margaret Hamburg, former Health Commissioner of New York City, as FDA Commissioner. . See the next section for news of an additional development at Wellpoint. On the Blood Safety front, excerpts from recent FDA Enforcement Reports can be found at the end of this Update as Attachment #4. . > INDUSTRY . According to the Financial Times of March 5th, Wellpoint is attempting to sell its specialty pharmacy, NextRx, a mail-order pharmacy warehouse operation in Indiana, which Wellpoint forced all Blue Cross members who were persons with hemophilia to use. (NextRx serves many other Wellpoint customers as well.) Wellpoint customers have not had choice in provision of factor: they have not had the ability to go elsewhere if they find arrangements with one of the providers inadequate. No buyer has been announced, and so the fate of these customers is unknown. Wellpoint may convey its customer list (and their insurance contracts) to the buyer, or agree to continue service for some period, for example. The Times indicated that such sales might be seen from other insurers with their own pharmacies as well, as the US financial situation becomes increasingly challenging. It also noted that the possible advent of a great increase in the number of insured, resulting from the new Administration’s efforts toward health care reform, and recent announcement of reductions in Medicare payment rates, were likely factors contributing to the decision to sell. . In early March COTT learned of an HTC presenting patients with a liability waiver, which if signed, holds harmless that particular HTC from a legal responsibility for an injury associated with the treatment of hemophilia. This could be triggered by the UK finding of vCJD in a person with hemophilia. It is deeply troubling when the institution an individual or family depends on for their hemophilia care is asking or demanding to be legally protected from known or unknown risks associated withy the treatment of hemophilia. For a community still recovering from the twin epidemics of HIV/AIDS and HCV it is tantamount to adding insult to injury. If our products are as safe as we believe, then why is it necessary to indemnify a given hemophilia treatment provider against legal liability? . > COTT Operations . The Washington DC 20th COTT Anniversary celebration event has been shifted from July to October of this year. In addition, a joint session with the Hemophilia Federation of America (HFA) has been added, for reunion and mobilization centered around those in the community who have survived the HIV and hepatitis C infections that befell us so viciously, triggering the creation of COTT, and who have worked to create an organization that is vigilant concerning the threats to the safety of the blood supply from all quarters. The Celebration event to follow the above session, will be the centerpiece of the occasion. It will include reviews of our history, recollections from key players in that history, and remarks from policymakers who stood by us throughout and look to us to help in the important work ahead of us. In addition, there will be a film festival the night before, a showing of a variety of hemophilia-related films which serve to make the history come alive. . COTT joined with HFA in presenting a legislative training for the Maryland association on March 2nd , including review of state websites on the flow of Economic Stimulus funds, role-playing and emphasis on describing the situation of the hemophilia community as one with a high-cost, chronic condition. . COTT participated in HFA’s first symposium, March 12-14 2009 in Indianapolis, under its new Executive Director, Kimberly Haugstad. We appreciate their support for COTT’s Town Meeting, and for a well produced and moving Memorial Service. We are looking forward to a new era of cooperative work between the Hemophilia Federation and the Committee of Ten Thousand. . . COTT acknowledges the assistance of Hemophilia Health Services and Factor Support Network in publication of this issue of the COTT Washington Update.
Committee of Ten Thousand 236 Massachusetts Ave., NE Suite 609 Washington, DC 20002 800-488-2688 * 202-543-6720 fax cott-dc@earthlink.net * WWW.COTT1.ORG
Attachment #1: UK Health Agency Report on Spleen vCJD Case vCJD abnormal prion protein found in a patient with haemophilia at post mortem 17 February 2009 Evidence of infection with the agent (abnormal prion protein) that causes variant Creutzfeldt-Jakob Disease (vCJD) has been found at post mortem in the spleen of a person with haemophilia.
The patient, who was over 70 years old, died of a condition unrelated to vCJD and had shown no symptoms of vCJD or any other neurological condition prior to his death. The vCJD abnormal prion protein was only identified during post mortem research tests. The Health Protection Agency is working with the UK Haemophilia Centre Doctors Organisation to ensure all patients with bleeding disorders are made aware of this preliminary information which is being further investigated. This new finding will not change the way patients with haemophilia are cared for or treated. . A final view as to how vCJD abnormal prion protein was transmitted to this haemophilia patient has yet to be reached because investigations are continuing to determine the most likely route of transmission. It is known that the patient had been treated with several batches of UK sourced clotting factors before 1999, which is when measures to improve the safety of blood in relation to vCJD were introduced. The patient's treatment had included one batch of Factor VIII that was manufactured using plasma from a donor who went on to develop symptoms of vCJD six months after donating the plasma in 1996. . This is the first time that vCJD abnormal prion protein has been found in a patient with haemophilia, or any patient treated with plasma products. This new finding, however, does not change the public health vCJD 'at risk' status of patients with bleeding disorders. . Haemophilia patients have previously been informed by their doctors of their possible increased risk of exposure to vCJD via clotting factors. In 2004 all patients with bleeding disorders who had been treated with UK-sourced pooled plasma products between 1980 and 2001 were told that, owing to potential vCJD infectivity from these products they were to be classified as at-risk of vCJD for public health purposes. . Professor Mike Catchpole, Director of the Health Protection Agency's Centre for Infections, said: "This new finding may indicate that what was until now a theoretical risk may be an actual risk to certain individuals who have received blood plasma products, although the risk could still be quite low. We recognise that this finding will be of concern for persons with haemophilia who will be awaiting the completion of the ongoing investigations and their interpretation. . The priority is to ensure that patients are informed of this development and have access to the latest information and specialist advice from their own haemophilia centre doctor as soon as possible. . “This finding does not change our understanding of the risk from vCJD for other people in any specific way. But it does reinforce the importance of the precautionary measures that have been taken over the years. . “Since the risk of vCJD transmission through blood was first considered, a number of precautionary measures have been introduced to minimise the risk from the UK blood supply. UK plasma has not been used for the manufacture of clotting factors since 1999 and synthetic clotting factors are provided for all patients for whom they are suitable.”
Ends Notes for editors . 1) The post-mortem tests were carried out as part of a research study jointly coordinated by the UK Haemophilia Centre Doctors Organisation and the National CJD Surveillance Unit. The study was commissioned in 2001 and is ongoing. . 2) The likelihood of a person who is infected with the vCJD abnormal prion protein going on to develop symptoms of the disease is uncertain and may depend on individual susceptibility. It is possible that infected individuals may never develop symptoms. . 3) Haemophilia is a genetic blood condition in which an essential clotting factor is either partly or completely missing. This causes a person with haemophilia to bleed for longer than normal. Treatment for haemophilia is usually by replacing the missing clotting factor (factor VIII) through regular injections which helps the blood to clot and minimises the likelihood of long term joint damage. . 4) In 2004 all patients with bleeding disorders who had been treated with UK-sourced pooled plasma products (e.g. clotting factors for individuals with haemophilia) between 1980 and 2001 were told that, owing to potential vCJD infectivity from these products, they would be classified as at-risk of vCJD for public health purposes. . The start date of 1980 is thought to be the earliest date the agent (abnormal prion protein), that causes BSE in cattle and vCJD in humans, could have entered the food chain. The end date of 2001 is the last possible expiry date of any product manufactured by UK fractionators that had been sourced from UK donors up until 1998. . 5) The government introduced a number of measures from 1997 onwards to safeguard blood and plasma supplies.
- Since 1997 all cases of vCJD that are reported to the National CJD Surveillance Unit and diagnosed as having 'probable' vCJD, result in a search of the UK Blood Services blood donor records. If the patient has donated blood, any unused parts of that blood are immediately removed from stock. The fate of all used components of blood from the donor is traced, and surviving recipients informed of their risk.
- In July 1998, the Department of Health announced that plasma for the manufacture of blood products, such as clotting factors, would be obtained from non-UK sources.
- Since October 1999, white blood cells (which may carry the greatest risk of transmitting vCJD) have been removed from all blood used for transfusion.
- In August 2002 the Department of Health announced that fresh frozen plasma for treating babies and young children born after 1 January 1996 would be obtained from the USA, extended to all children under 16 years of age (Summer 2005).
- In December 2002, the Department of Health completed its purchase of the largest remaining independent US plasma collector, Life Resources Incorporated. This secures long-term supplies of non-UK blood plasma for the benefit of NHS patients.
- Since April 2004, blood donations have not been accepted from people who have themselves received a blood transfusion in the UK since 1980. This has been extended to include apheresis donors and donors who are unsure if they had previously had a blood transfusion (August 2004).
- Since late 2005, blood donations have not been accepted from donors whose blood was transfused to patients who later developed vCJD.
- The UK Blood Services continue to promote the appropriate use of blood and tissues and alternatives throughout the NHS.
6) Specialist advice and care concerning vCJD is available from: The National CJD Surveillance Unit, based at the Western General Hospital Edinburgh: www.cjd.ed.ac.uk. The NHS National Prion Clinic, based at The Hospital for Neurology and Neurosurgery, Queen Square, London http://www.nationalprionclinic.org/
7) For further information about vCJD go to: www.hpa.org.uk/cjd http://www.hpa.org.uk/vcjdplasmaproducts http://www.dh.gov.uk/PolicyAndGuidance/HealthAndSocialCareTopics/CJD/fs/en http://www.blood.co.uk/ http://www.cjd.ed.ac.uk http://www.nationalprionclinic.org/ . . Attachment #2: COTT Press Release on UK Spleen vCJD Case
Committee of Ten Thousand Advocates for People with HCV, HIV, & AIDS www.cott1.org / cott-dc@earthlink.net
UK Finds Mad Cow Can Be Transmitted through Blood Supply
Washington, DC February 19, 2009 -- The Committee of Ten Thousand (COTT) is deeply troubled by the news of the discovery of vCJD, the human-transmissible variant form of Mad Cow disease, in a person with hemophilia in the United Kingdom. People with hemophilia world-wide depend on clotting factor, produced from human plasma, to control their bleeding episodes. While genetically-engineered, recombinant clotting factors are now available, plasma derived products continue to be widely used for the treatment of hemophilia and other bleeding disorders. The UK case is person with hemophilia, over 70 years old, who was exposed to variant CJD through the plasma derived clotting factor he received in the late 1990s. He died of unrelated causes and during the autopsy variant CJD was found in his spleen. This individual was known to have received plasma-derived clotting factor produced, in part, from a donor who subsequently developed variant CJD. . This means that all 4000 persons with hemophilia in the UK are at risk of contracting vCJD from the plasma-derived clotting factor they used during the 1990s. It also raises serious questions about the risk of CJD and variant CJD transmission in the American hemophilia/ bleeding disorders community. . COTT is angered that the US Department of Agriculture has failed to conduct a substantive and wide reaching surveillance program for cows in the US. For example, major slaughter-houses, such as that seen in last year’s video of cows which could not walk (often a sign of Mad Cow) being shoveled into line with fork lift trucks for slaughter into hamburger and steaks for the American public, were exempted. . We demand that the Obama Administration and the new leadership at the Department of Agriculture begin the development and implementation of a much wider surveillance program for American cattle without delay. We also demand a more aggressive presence on Mad Cow Safety in the US from the Food and Drug Administration, where the Mad Cow Advisory Committee has not even met since December of 2006. We join in solidarity with the UK hemophilia community, who led by Haemophilia Action UK have been at the forefront of publicizing the risks for the end users of blood/blood products in the United Kingdom and in the US as well. . We call on FDA’s Center for Biologics Evaluation & Research to immediately schedule a public meeting of the Mad Cow Advisory Committee, inviting officials in the UK, and further investigating the implications of this serious and troubling discovery for the end users of blood and blood products in the United States. CONTACTS: Washington: Board Chair / President: Dave Cavenaugh Corey Dubin Government Relations Santa Barbara, CA 202-543-0988 805-697-6679 Mobile 202-841-9805 Mobile 805-886-3846
Attachment #3: 2007 UK article: Testing hemophiliacs without permission
Patients' fury over blood test 'betrayal'
Doctors at NHS hospital carry out 'mad cow' analysis without permission . Ned Temko The Observer, Sunday 3 June 2007 . Doctors were accused of gross betrayal last night after haemophiliac patients discovered that their blood samples were being tested for the human form of 'mad cow' disease without their knowledge. . They compared the move by one of Britain's leading NHS hospitals to the Alder Hey organ scandal, when samples were taken from the bodies of dead children without their parents' permission. . The secret blood testing for new variant CJD was discovered in the minutes of a meeting of America's Food and Drug Administration, which was attended last year by a leading member of Britain's National Institute for Biological Standards Control. . The minutes revealed that the British scientist told the FDA that haemophiliac blood samples taken from the Royal Free Hospital in London would be 'provided for variant CJD analysis'. He described the samples as 'a bit of serendipity' that could provide 'icing on the cake' for testing the development of an effective blood test for the disease. . Last night testing was criticised by Professor Christine Lee, until recently the head of the Royal Free's haemophilia unit, who said that passing on blood samples without patients' knowledge or consent raised serious ethical issues - particularly in the wake of controversies like the Alder Hey organ scandal. . 'You can't go around just grabbing stored samples,' she said. Acknowledging that she had used samples for hepatitis and HIV infection research 'at an earlier time' in her two decades at the hospital, she said that attitudes had changed. 'You can't go ahead and test people without their knowledge. It's just not on.' . She said she had been shocked when she had learnt of the disclosure of the blood testing plan and had strongly urged both the institute and her successor at the Royal Free, Professor Edward Tuddenham, to drop the idea. . But when contacted yesterday Tuddenham said: 'Yes, we are in the process of transferring them [the blood samples] to the CJD surveillance group at the National Institute for Biological Standards Control. We still have them in the freezers here.' He said the samples had been taken during testing for hepatitis C and HIV, but that those analyses were finished and the samples 'were just going to be incinerated otherwise'. . 'I got in touch because it occurred to me that the CJD people might be interested, and they were indeed extremely interested. So I was pleased to find a useful research end for the samples.' . But patients are demanding that the blood testing be halted until they have been consulted. 'I'm sickened by this,' said Mark Ward, 38, a longtime haemophiliac patient at the Royal Free. Ward, who contracted HIV from US-sourced blood but was not informed until the hospital had tested him for the virus without his knowledge, said: 'They're doing the same to us as they did 20 years ago.' . He said that, if asked, he might agree to have his blood samples used to speed the development of a test for vCJD. But to do so without telling him was 'simply wrong,' he said. 'We live in a world where we are supposed to have rights, but I feel I'm being treated like a laboratory rat.' . Though the Royal Free knows the identity of the sample donors, the plan is to 'anonymyse' them for the purpose of the variant CJD research. . But Lee warned her successor that even that approach was fraught with enormous 'patient counselling issues'. She said that, if indications of vCJD were found in any of the samples, the question would arise of whether and how to inform the individual of the possible health risks to himself or others. She said the hospital's plan 'has to come above the parapet. The patients have got to know about it - and give explicit permission'. . So far 160 people in Britain have contracted variant CJD, including four transfusion patients who have either begun showing signs of the disease or were found to have symptoms following a post mortem. So far, no haemophiliac has developed the disease, but concern has centred on the fact that two dozen batches of blood used for transfusion have included samples given by people who went on to contract the disease. . http://www.guardian.co.uk/medicine/story/0,,2094321,00.html
. . Attachment #4: Recent FDA Enforcement Report excerpts . February 11 ___________________________________ PRODUCT Whole Blood CPDA-1, Recall # B-0468-09 CODE Unit: LJ45957 RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI, by fax on February 23, 2006. Firm initiated recall is complete. REASON Blood product, that was not quarantined after receiving information concerning post-donation illness, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit DISTRIBUTION WI ___________________________________ PRODUCT Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0470-09 CODE Units: 303549812, 303549872 RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Fargo, ND, by telephone on April 16, 2006. Firm initiated recall is complete. REASON Blood products, which may have reached an unacceptable temperature during shipment, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION ND
February 18 ___________________________________ PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-0464-09; b) Recovered Plasma. Recall # B-0465-09 CODE a) and b) Unit: S93413 RECALLING FIRM/MANUFACTURER Central Illinois Community Blood Center , Springfield , IL , by facsimile or e-mail on August 5, 2008 and by letter dated August 5, 2008. Firm initiated recall is complete. REASON Blood products, which were incorrectly tested for Hepatitis B surface antigen (HBsAg), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION IL, RI ___________________________________ PRODUCT Platelets Pheresis Leukocytes Reduced, Recall # B-0497-09 CODE Unit: 72H908112 RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc, Dunwoody , GA , by telephone on November 17, 2008. Firm initiated recall is complete. REASON Blood product, with platelet count below the specified minimum requirement, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit DISTRIBUTION GA ___________________________________ PRODUCT Red Blood Cells Leukocytes Reduced, Recall # B-0496-09 CODE Unit: FS14374 RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee , WI , by fax on March 9, 2006. Firm initiated recall is complete. REASON Blood product, which may have reached an unacceptable temperature during shipment, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit DISTRIBUTION NJ ___________________________________ PRODUCT Platelets, Recall # B-0480-09 CODE Unit: 7968711 RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford , TX , by telephone on August 23, 2007 and follow up letter dated August 30, 2007. Firm initiated recall is complete. REASON Blood product, prepared from a whole blood unit that had an extended bleed time documented, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit DISTRIBUTION TX
February 25 ___________________________________ PRODUCT Source Plasma, Recall # B-0474-09 CODE Unit: 4530094821 RECALLING FIRM/MANUFACTURER ZLB Plasma Services of Melrose Park, Melrose Park, IL, notified electronically on July 11, 2008. Firm initiated recall is complete. REASON Blood product, tested for viral markers using a diluted sample, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit DISTRIBUTION Germany _________________________________ PRODUCT Platelets Pheresis Leukocytes Reduced, Recall # B-0501-09 CODE Units: 7121983 (Part 1 and Part 2) RECALLING FIRM/MANUFACTURER Recalling Firm: New York Blood Center, Inc., Long Island City, NY, by telephone and follow-up facsimile on June 22, 2007. Manufacturer: New York Blood Center, Inc., Westbury, NY. Firm initiated recall is complete. REASON Platelets, which were contaminated with Propionibacterium species, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION NY _________________________________ PRODUCT a) Cryoprecipitated AHF, Recall # B-0514-09; b) Platelets, Recall # B-0515-09; c) Fresh Frozen Plasma, Recall # B-0516-09; d) Red Blood Cells Leukocytes Reduced, Recall # B-0517-09; e) Recovered Plasma, Recall # B-0518-09; f) Source Leukocytes, Recall # B-0519-09 CODE a) Unit: 5917949; b), c) Unit: 5980622; d) Units: 5917949; 5980622; e) Unit: 5917949; f) Unit: 5980622 RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX, by facsimile on June 27, 2007, July 2, 2007 and July 5, 2007. Firm initiated recall is complete. REASON Blood products, collected from a donor who was permanently deferred, were distributed. VOLUME OF PRODUCT IN COMMERCE 7 units DISTRIBUTION TX, NJ, CA ___________________________________ PRODUCT a) Platelets, Recall # B-0523-09; b) Red Blood Cells Leukocytes Reduced, Recall # B-0524-09 CODE a) and b) Unit: 2822061 RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX, by telephone on March 16, 2007 and by letter dated April 9, 2007. Firm initiated recall is complete. REASON Blood products, collected from a donor who was at risk for HIV Group O, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION TX __________________________________ PRODUCT a) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0502-09; b) Platelets Pheresis Leukocytes Reduced, Recall # B-0503-09 CODE a) Unit: 036FM50919; b) Units: 036FJ12501, 036FJ12507, 036FM50904, 036FM50909, 036FM50921 (Part 1), 036FM50921 (Part 2), 036FM50928 RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Birmingham, AL, by telephone on February 6, 2007 and letter dated February 10, 2007. Firm initiated recall is complete. REASON Blood products, in transit longer than 24 hours and without constant agitation, were distributed. VOLUME OF PRODUCT IN COMMERCE 8 units DISTRIBUTION AL March 11 _________________________________ PRODUCT Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0493-09 CODE Unit: KX24696 (Part 1 and 2) RECALLING FIRM/MANUFACTURER Mid-South Regional Blood Center, Memphis, TN, by letter on July 30, 2008. Firm initiated recall is complete. REASON Blood products, collected from a donor who was taking the drug Prednisone, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION TN Source Plasma, Recall # B-0474-09Unit: 4530094821ZLB Plasma Services of Melrose Park, Melrose Park, IL, notified electronically on July 11, 2008. Firm initiated recall is complete.Blood product, tested for viral markers using a diluted sample, was distributed.1 unitGermany Platelets Pheresis Leukocytes Reduced, Recall # B-0501-09Units: 7121983 (Part 1 and Part 2)Recalling Firm: New York Blood Center, Inc., Long Island City, NY, by telephone and follow-up facsimile on June 22, 2007.Manufacturer: New York Blood Center, Inc., Westbury, NY. Firm initiated recall is complete.Platelets, which were contaminated with Propionibacterium species, were distributed.2 unitsNYa) Cryoprecipitated AHF, Recall # B-0514-09;b) Platelets, Recall # B-0515-09;c) Fresh Frozen Plasma, Recall # B-0516-09;d) Red Blood Cells Leukocytes Reduced, Recall # B-0517-09;e) Recovered Plasma, Recall # B-0518-09;f) Source Leukocytes, Recall # B-0519-09a) Unit: 5917949;b), c) Unit: 5980622;d) Units: 5917949; 5980622;e) Unit: 5917949;f) Unit: 5980622 Gulf Coast Regional Blood Center, Houston, TX, by facsimile on June 27, 2007, July 2, 2007 and July 5, 2007. Firm initiated recall is complete.Blood products, collected from a donor who was permanently deferred, were distributed.7 unitsTX, NJ, CAa) Platelets, Recall # B-0523-09;b) Red Blood Cells Leukocytes Reduced, Recall # B-0524-09a) and b) Unit: 2822061Carter BloodCare, Bedford, TX, by telephone on March 16, 2007 and by letter dated April 9, 2007. Firm initiated recall is complete.Blood products, collected from a donor who was at risk for HIV Group O, were distributed.2 unitsTXa) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0502-09;b) Platelets Pheresis Leukocytes Reduced, Recall # B-0503-09a) Unit: 036FM50919;b) Units: 036FJ12501, 036FJ12507, 036FM50904, 036FM50909, 036FM50921 (Part 1), 036FM50921 (Part 2), 036FM50928 American Red Cross Blood Services, Birmingham, AL, by telephone on February 6, 2007 and letter dated February 10, 2007. Firm initiated recall is complete.Blood products, in transit longer than 24 hours and without constant agitation, were distributed.8 unitsAL Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0493-09Unit: KX24696 (Part 1 and 2) Mid-South Regional Blood Center, Memphis, TN, by letter on July 30, 2008. Firm initiated recall is complete.Blood products, collected from a donor who was taking the drug Prednisone, were distributed. 2 unitsTN
|
|
|
Washington Update is a bi-monthly primer on government related issues of importance to COTT's constituency. From health care legislation, to regulatory affairs to Administration policy for chronic diseases. A hands-on journal for grass roots health care advocacy in our Nation's capital.
|
 |
COTT News A range of information, reportage and viewpoints regarding issues and events of importance to grass roots health care advocacy and support. In COTTÂ’s vision information is power and part of the empowered community equation. From Washington D.C. to State capitals to the HIH and the FDA, look to COTT for grass roots health care news.
|
 |
COTT Canary tracks safety issues in our Nation's blood supply. It provides regular reporting, information and viewpoints from the grass roots end user communities. It is based on the historical practice of taking Canaries into the coalmines to gauge problems with breathable air. If the Canary passed out then it was time to evacuate the mine. Persons with hemophilia and other bleeding disorders are the canaries in the coalmine, the blood supply. If problems are present they will surface first in the hemophilia community.
|
 |
Treatment Updates: News, information and analysis about living with HIV/AIDS, hepatitis C, and hemophilia and related problems associated with living with multiple life threatening diseases.
|
 |
|