2010-09-07 | Welcome
Posted by Dave Cavenaugh   06-23-2009 WASHINGTON UPDATE
Volume 11 Number 3

> STATE ISSUES


California – California continues to be of great concern for our community given the high cost of hemophilia/bleeding disorders treatment and the monumental deficit the State is currently facing. Even more disconcerting for the HIV/AIDS infected hemophilia community are the proposed cuts in HIV/AIDS funding: both treatment and prevention are slated for serious funding cuts.


California’s deficit is the largest of any state in our nation at between $20 and 25 billion dollars depending on numbers used. It is deep enough to mean draconian cuts in the State’s social services programs, especially health care. Access to health care is to be greatly limited, as is State reimbursement for that care. Those most in need in California are precisely to be those most severely impacted by the cuts.

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The Hemophilia Council of California, working proactively and consistently with the local organizations and the community’s three national organizations as well, have helped to assure that the Genetically Handicapped Persons Program (GHPP) and Crippled Childrens Services (CCS), the two main California public insurance programs for hemophilia and other bleeding disorders, will survive the current  round of draconian cuts.


There has been some important give and take between the State and the community this year. Discussions in May concluded with agreement that the proposed GHPP enrollment fee increase was an area where the community could compromise given the dire budget landscape facing California and, in fact, GHPP enrollment fees have not been raised in over ten years. The State in turn agreed to provide premium support for members of our community thereby keeping some individuals under private insurance. While welcome, this will be on a case by case basis which raises some concerns for COTT regarding questions of equity in terms of who ultimately GHPP decides to provide premium support for.
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The Hemophilia Council has also asked the State to reduce the six-month waiting period for new enrollment to 45 days, and been granted language that would ensure the involvement of all stakeholders from the bleeding disorders community in any future proposed changes.
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COTTWEST has been working closely with the Council and Hemophilia Foundation of Southern California in support of a continued strong voice for the California’s bleeding disorders community. Special thanks to Terri Cowger Hill, Yvette Bryant, and Tony Maynard of the Council for a job well done in the midst of a very difficult situation. This is a good example of how important it is for local and regional community organizations to take the lead at the state level. It is also a very good example of organizations working cooperatively and collaboratively in defense of our community.

Unfortunately the news is not as good regarding HIV/AIDS and California.  Governor Schwarzenegger’s most recent budget revisions include more than 80 million dollars in cuts in HIV/AIDS programs, including the AIDS Drug Assistance Program, ADAP, as well as education and prevention programs designed to prevent the further growth of the AIDS epidemic.

Early intervention programs, housing support, case management, and critical prevention interventions will be no longer be available in California if these cuts are adopted in the final budget. According to one AIDS activist in Southern California, “California is balancing the budget on the backs of those most in need. This will surely cost lives in the AIDS community if the proposed cuts are adopted.”

As of June 22nd the Budget Conference Committee between the Assembly and the Senate has completed its work and is forwarding a revised budget to both chambers of the California Legislature for a proposed vote.   According to the Department of Finance in the Governors office, the State still faces a $24 billion dollar shortfall that will need to be addressed through a combination of additional revenues and further cuts in existing programs. Recent history suggests that there will be a long series of votes before a budget is approved. Sources in Sacramento tell COTT that the proposed budget will be voted down this week due to longstanding minority Republican opposition to any new revenue proposals. If this occurs the Governor will convene the “Big Five” – himself, leaders of the two houses of the legislature, and of the two parties.  This group as in other recent deficit-resolving votes will hammer out a solution and present it as a fait accompli to the legislature for approval.

> CONGRESS

In late May, draft health reform legislative language began to be circulated among members of the Senate Finance Committee and the House Energy & Commerce committee.  Senator Edward M. Kennedy (D-MA) in the first week of June released a 170-page draft bill. In both Finance, under Chairman Max Baucus (D-MT) and HELP, the Health, Education, Labor and Pensions Committee that Kennedy chairs, these first drafts are the Chairman’s own, and, despite input from members to date, are not being held up as committee products.  Kennedy’s brings sighs of relief to the rare chronic disease community and others with similar needs.  It requires insurers to cover persons despite pre-existing conditions; mandates individual purchase of coverage, although with a heavy plan for subsidies, and require employers to offer health plans. It is a high-end bill, requiring substantial revenues for operation which are not specified to date.

The plan the Senate Finance Committee has produced rejects the inclusion of a public program to care for those falling outside the range of private insurers.  Even the President, strongly in favor of such a component during the Campaign, has been heard to say it’s “on the table,” meaning ‘chopping block.’ Republican equating of any public program with complete socialized medicine is part of the reason Democrats are leaning away from it, despite its being completely baseless attack-ad tactics.  Which, unfortunately, often work. 

A much worse development is the idea in circulation in both of these hatcheries to tax health benefits.  The logic is that only those who are well-off and have ample health insurance coverage would see their ‘excess’ benefits tapped.  This completely ignores any discussion of chronic disease communities such as hemophilia who desperately need their high-cost, high benefit-payout medications just to survive and remain productive members of society.  This MUST be opposed.  It is a seductive idea, as it is expected to raise Billions of dollars toward the costs of implementing broad-coverage health reform. 
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We must show them what the price would be. COTT readers should write their own Senators and Congresspersons without delay to oppose creation of any draft reform package that lacks a public program, and to vote and work against any proposal to fund health care reform by taxing health benefits.   Attachment #1 to this Update is a reprint of a recent Washington Post article concerning the benefits question.  Attachment #2 is a letter recently prepared by a broad consensus of plasma-using communities and others, to the Chairs of these committees, asking them to fairly include the needs of those with rare and chronic conditions in the drafts they are formulating.

> ADMINISTRATION & AGENCIES

The end of April marked the first hundred days of the new Administration.. Legions of pundits compared his productivity during this period to that of former Presidents, going all the way back to FDR.  He has started many new initiatives and programs, clustered in five main areas (government reform, health care reform, the economy, foreign affairs, and energy/climate). 

Primary among these, from our point of view, was the confirmation and installation of Kathleen Sebelius, former Governor of Kansas, as Secretary of the Department of Health and Human Services.  With this and finalization of a few subordinate positions, the Department has finally been able to come up to full operation.
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Swine Flu
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After a rapid outbreak across Mexico, with a disturbingly high proportion of fatalities, a ‘human/swine’ influenza proceeded around the world, although the mortality rate was never as high as in the initial stages.  As of June 19 the CDC reported 21,500 cases in the US, with 87 deaths; estimated number of cases worldwide was 52,000 with 237 deaths, although experts point to specific countries with high populations and low reporting rates, indicating that this number could be a severe undercount.  The number of fatalities remains low, both overall and as a percentage of cases.  Cases have been reported in the hemophilia community; immunocompromised individuals should increase precautions.
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The FDA Blood Products Advisory Committee (BPAC)
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On April 1st and 2ND the BPAC met in Maryland. As always COTT was in attendance, both in the audience and at the table to ensure a grass roots voice in this critical FDA advisory committee. COTT Board member, Dr. Rich Colvin, MD PhD, of Massachusetts General Hospital, sits as a voting member on behalf of the Committee of Ten Thousand. Dr. Colvin brings to the table his expertise as a medical researcher and clinician, while also providing a strong perspective rooted in the HIV/AIDS and HCV infected hemophilia community. In the COTT tradition, Dr. Colvin always places issues of safety in the larger context of the blood supply and all those who depend on its stability and safety to retain their health and wellness.
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On this meeting’s agenda was the explosive issue of “recovered plasma” and its use in the manufacture of blood products such as factor concentrates, immune-globulins, albumin and others. Recovered plasma is the plasma left over following a whole blood donation at a community blood center such as the American Red Cross, the American Association of Blood Banks, or Americas Blood Centers to name most of the organizations collecting whole blood and blood components in the US.
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In the late 1980s and early 1990s recovered plasma was viewed as less safe as it was not subjected to the same safety standards as source plasma which is collected solely for use in the manufacture of blood products. Since it is subjected to a less stringent set of standards than source plasma, the community and others demanded its exclusion from blood products in the 1990s. What the community did not understand was that a window was left open so the manufacturers, when they ran short of source plasma, could purchase recovered plasma from the blood banks and community blood centers under “short-sale agreements.” What remains unclear to COTT is the volume of recovered plasma going into the plasma pools for manufacturing under such agreements. At issue at the meeting were new regulations, proposed by FDA, to bring the short-sale agreements under tighter regulatory control. Also under discussion was transparency and donor health.
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In the public comment segment COTT President Corey Dubin expressed COTT’s ongoing concern regarding recovered plasma and its use in the manufacturing of blood products. He placed the issue in its all-important historical context and illuminated why it remains an explosive issue for those in the hemophilia community severely harmed by the blood borne epidemics of HIV/AIDS and hepatitis C.
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While we support FDA’s initiative to bring the short-sale agreements more under regulatory authority, we are troubled by the issues of trust and transparency raised by the recovered plasma question. We are frustrated at the blood community’s lack of concern regarding the trust of the end users of this nation’s blood supply. Dr Colvin engaged in a heated exchange on this with Americas Blood Centers representative Celso Bianchi MD who sits in the non-voting industry seat on the BPAC. Dr. Colvin stated, “while we agree that donor health and trust are critical parts of the blood supply landscape, you never address the issue of end user trust and the transparency necessary to rebuild that trust. This is especially true in communities such as hemophilia which were so severely harmed by the failure of the entire US blood system.” Dr. Colvin expressed our frustration at what he viewed as the generally negative stance the blood community has toward new regulations.
 
Following the exchange between Dr. Colvin and Dr. Bianchi, the BPAC Chair, Dr. Fredrick Segal asked Mr. Dubin to return to the microphone and expand on his reference to the “dark forces” which the community associates with the AIDS/blood epidemic and the transmission of HIV/AIDS and hepatitis C to thousands in the hemophilia community. Mr. Dubin cited three issues in response:  1.) The misinformation emanating from the manufacturers regarding plasma pool size during the 1970s and 1980s when the community was consistently informed that plasma pools were comprised of 30,000 donors. We now know that plasma pools were, in many instances, 10 times that number and frequently in the 100,000 donor range. 2.) The failure of the blood community and the federal government to address the four-decade presence of hepatitis in this nation’s blood supply and the conscious downplaying of the potential impact of non-A, non-B hepatitis on the users of factor concentrates. 3.) The usage of plasma collected from donors with a history of hepatitis when the regulations clearly stated that donors with a history of viral hepatitis should not be used in the production of factor concentrates. The plasma from these donors, while critical to the manufacture of immune-globulins, should not have been pooled with the plasma from donors free of hepatitis, as it significantly increased the risk of HIV transmission to the users of factor concentrates.
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We now know and are living with the impact of a devastating HCV epidemic in the hemophilia community. We also now know that for many of us co-infected with HIV/AIDS and HCV, it is the liver failure associated with HCV that is frequently the ultimate cause of death. For us, the question becomes, who shoulders the ultimate risk when the blood community fails? The end users shoulder the ultimate risk, and yet we continue to have to struggle and fight to be adequately represented on the appropriate DHHS and FDA advisory committees associated with the safety and efficacy of our nation’s blood supply. We seek a partnership with the federal government and the blood community that ensures the equitable participation of all the stakeholders associated with America’s blood supply and its management.
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These issues are reflective of the trust and transparency concerns COTT and our community remain troubled by. We are frustrated by the ongoing resistance of the blood community to viewing the situation as one of a joint approach to the risk associated with the blood supply and how we address those risks as providers and end users. We hear that we do not understand the risk equation and seek a zero risk landscape. This is absurd as we are the ones living with the risk each and every day.
We intimately understand the need to asses different degrees of risk and the likelihood that a given risk will lead to end user harm.
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Transparency and trust building initiatives remain a necessary part of the blood landscape if we are to understand and trust each other as stakeholders of the blood supply. The idea, expressed more often than not, that the survivors of the HIV/AIDS and HCV infected hemophilia community are barriers to moving forward only serves to deepen our concern that the twin blood borne epidemics of HIV/AIDS and HCV are to be forgotten. For our community, this can only leave us with a foreboding sense that our loved ones died in vain.
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Advisory Committee on Blood Safety and Availability (ACBSA)
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The DHHS Advisory Committee on Blood Safety and Availability also met, concerning issues more directly of relevance to COTT and the hemophilia community: increasing the degree to which cost is considered in evaluating therapies, as the work of several Comparative Effectiveness Review panels gets under way.

The meeting, on April 30th and May 1st, was the Committee’s first meeting since the inauguration of the Obama Administration. In addition to swearing in new members and getting started with the new Administration, the Committee reviewed the impact of cost in decisions regarding the safety of the blood supply. For COTT, this discussion represented a déjà vu regarding the AIDS/blood and hepatitis C epidemics that devastated the hemophilia community. As stated in COTT’s testimony before the ACBSA, is included in this Update as Attachment #3. “Cost effectiveness visited wide-spread suffering and death in the hemophilia community” as it was the primary reason that hepatitis was allowed to remain unaddressed in the American blood supply for decades. Had hepatitis contamination been addressed in the 1970s, HIV/AIDS would have been a footnote in hemophilia rather than the devastating epidemic it became. COTT is adamant in our opposition to cost effectiveness being resurrected as the overriding guidance for critical decisions regarding the safety of the nation’s blood supply. Again, from our perspective, it is a question of how safety related decisions are interwoven with the question of risk and who shoulders the ultimate risk when the blood system fails?
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The FDA BPAC meeting and the DHHS ACBSA meeting when considered in tandem have left us with an even deeper concern that we are in danger of forgetting or abandoning the lessons learned from the twin blood borne epidemics of HIV/AIDS and hepatitis C. When the blood community, with the apparent support of the government, seeks to resurrect cost effectiveness as a principle guidance for safety related decisions, we in end user communities must again remind all concerned of the magnitude of the failure of the 1970s and 1980s, and in good conscience ask, what is the blood community and the federal government thinking?  When the cost associated with increased safety is discussed, we never hear or see an analysis of the cost associated with failure. We never hear about the cost associated with treating those infected with HIV/AIDS and HCV from tainted factor concentrates. This cost is never factored in as part of the equation. Given that, how can we ascertain that a given test or donor screening improvement is overly expensive? What are the real costs of s safer blood supply, and how do we view those additional costs if we do not consider the cost of failure, both economic and human.
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COTT is also concerned about the make-up of the ACBSA. The Committee is dominated by the blood banking side of the blood community and again end users are under represented. There is also a real lack of individuals who are familiar with the so-called blood wars of the 1980s and 1990s. We believe that incoming members of the ACBSA should, at a minimum, be required to read the Executive Summary of the National Academy of Sciences, Institute of Medicine report, “HIV and the Blood Supply, An Analysis of Crisis Decision Making”. The recommendations of the IOM report are what led to the establishment of ACBSA and remind the reader of the importance of understanding the failure of the blood community and the federal government to respond to HIV/AIDS in a timely manner. COTT also urges the Committee to revisit all fourteen of the IOM’s recommendations in the spirit of assessing where we have yet to substantively address issues that remain relevant over twenty years later.
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This is important, especially in light of recommendation 12 addressing the question of risk and how physicians and patients should address that risk. At the early April BPAC and again at this ACBSA meeting we again heard that end user communities such as hemophilia seek a zero risk landscape. Yet the ACBSA has never addressed recommendation 12 and the need to work with physicians and patients to understand and cope with the varying degrees of risk that patient will face in his/her lifetime from their dependence on the blood supply. This is just one example of an issue associated with the blood supply where this interagency committee has failed to address a component of an issue that is critical to any discussion of risk and how risk is addressed by providers and end users of the blood supply.
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Transmissible Spongiform Encephalopathies Advisory Committee (TSEAC)
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The FDA’s TSE Advisory Committee held its first meeting since 2006 on June 12th.  No further particulars on the case of prions found in the body of a person with hemophilia according to reports in February were reviewed; instead, various presentations and FDA Questions to the Committee focused on how safe the blood supply in the US is despite events in the UK, and how this incident, it was decided, did not call for any revisions in the FDA’s Risk Model, or any changes in screening. While there were US Department of Agriculture (USDA) staff present, there was no discussion of reactivating USDA’s cattle surveillance program, to determine if true risk was higher than determined to date.  COTT’s comments included this point, and the UK’s communications with the hemophilia community before and since this development. The testimony can be found as Attachment #4 to this Update.
 
> INDUSTRY
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PPTA Fly-In May 20
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COTT once again participated in the lobby day sponsored by the Plasma Protein Therapeutics Association (PPTA), on May 20th.  Over 70 visits were conducted by teams of three to five persons each, generally including at least one person from a consumer organization.  Issues of primary importance were IVIG pricing, lifetime caps legislation (both freestanding and if possible part of larger health reform proposals), and disturbing developments in the Comparative Effectiveness Review arena.
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PPTA Forum June 2-3
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COTT also participated in PPTA’s annual Plasma Forum, held June 2-3 in Washington.  One-half day of the two-day conference was devoted to a seven-presenter session on Surveillance, which we were a part of.  While most other presenters described one or more of the many surveillance databases out there, COTT railed against the need for such duplication, given that they are all inadequate since they are voluntary.  A copy of our testimony is included with this Update as Attachment #5.
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FTC crushes CSL / Talecris Merger
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On May 27 the Federal Trade Commission, which had been reviewing a request for CSL to acquire Talecris Biotherapeutics, announced its intention to take CSL to court to block the $3 Billion merger.  Its grounds were both that it would be illegal, and that it would unduly reduce competition in the already-tight plasma market.  An FTC Spokesman said, “Substantial consolidation has already occurred in the plasma protein industry, and these highly concentrated markets are already exhibiting troubling signs of coordinated behavior.” The complaint alleged that “firms in the plasma industry have used this consolidation as a tool to limit supply and drive higher prices, rather than to provide benefits for consumers.” Shares of market-leader Baxter’s parent company, Baxter International, fell nearly 4% on the news the FTC was hunting out collusion among the plasma companies. On June 8, CSL announced the merger was off, as the costs of the required litigation tipped the scales.
 
> COALITIONS
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The letter in Attachment #2 represents a strong example of a rapidly-developed, well-timed input by the high-cost, chronic disease community into the legislative development of health reform.  We are most pleased with this means of getting our communities on record in these debates; much more is needed.
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> COTT Operations
 
COTT’s 20th Anniversary Celebration and Seminar will be held October 2 & 3 in Washington, DC!  A reception, dinner and film festival on Friday night the 2nd will be followed Saturday by a Celebration of COTT’s history and work, with remarks from Congress and the FDA, stories from COTT Board and community members, and more.  In the afternoon a Senior Survivors Seminar will be held, to provide assistance with life issues experienced in our community. Plan to come for some or all!
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COTT finished a mail out of postcards to 3000 former COTT subscribers, inviting them to re-join after a several-year hiatus since our regular publication of Common Factor.  Although many families have lost a member with hemophilia to HIV and/or HCV in the meantime, some clearly are expressing a desire to continue working with us.  We welcome the many added to the Update mailing list with this issue.
 
BLOOD SAFETY SUMMARY
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Selections from current FDA Enforcement Reports are included in this Update as Attachment #6.
 
IN MEMORIAM – JAMES KREPPNER by Corey S. Dubin
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The men and women of the Committee of Ten Thousand are deeply saddened at the passing into the spirit world of one of the global hemophilia community’s most respected and loved activist and scholar, Mr. James Kreppner. James passed into the spirit world on May 14, 2009 from complications associated with his HIV/AIDS and hepatitis C which he, like so many of us, contracted from tainted factor concentrates used in the treatment of hemophilia. James, along with John Plater, Michael McCarthy and others led the fight for economic and social justice for Canada’s hemophilia community and all Canadians who contracted HIV/AIDS and hepatitis C from the blood supply. His impact was felt far beyond the borders of Canada as James was known across the global hemophilia community. He was a tireless and highly intelligent human being whose message was a beacon of light and empowerment for a chronic disease community devastated by the twin blood borne epidemics of HIV/AIDS and hepatitis C.
  
James brought passion and intellect to the community’s struggle for justice. His work inspired many of us and his memory will continue to serve as an example of what is possible. James was about what is possible both as an individual and as a member of a community in crisis. James was an empowered individual whose sense of self and the possible helped drive the struggle in Canada. I had the honor of first meeting James in the early 1990s when COTT members were invited to Toronto by the Toronto-Central Ontario Hemophilia organization to discuss working together across the border to uncover what had really occurred and how such a colossus failure could have happened. On that first visit COTT built productive and fraternal relationships with our brothers and sisters in Canada.
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We became even closer during the landmark Krever Commission, empanelled by the Canadian government to investigate the transmission of HIV/AIDS and hepatitis C through blood, blood components and blood products in Canada. COTT provided documents and information to Canadian RCMP investigators on a number of occasions and were honored to work with James and others in this important endeavor.
 
I had the honor of knowing James and my life was enriched by his presence in our world.
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In 2006 COTT had the honor of working closely with James and others at two all-important global conferences. In May of 2006 the World Federation of Hemophilia held its annual meeting in Vancouver. COTT Board members Chis Templin and Corey Dubin attended with COTT staff, John Rider and Dave Cavenaugh. Also present were COTT HepCats members Art McGowan, Marcus “The Marksman “ McClure, Greg McClure Jr., and Greg McClure senior, as well as lawyer Virgil Falloon who represented numerous community members in hepatitis C  litigation.
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On our second day in Vancouver Dave Cavenaugh and Chris Templin and myself met James for lunch. As we were sitting down James pulled off his sweatshirt and stated I remain a member in good standing of the Committee of Ten Thousand, showing off his 1995 hemophilia community COTT t-shirt. COTT was honored by this and were so very thankful to have a close relationship with one of the real heroes of what we have called the hemophilia holocaust.
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In August of 2006 we again found ourselves in Canada, this time for the World AIDS Conference. Since Toronto was James’ home this time we had the pleasure of spending time with James and Antonia at their flat in the city. As always we compared notes on the relative struggles of the hemophilia community in our respective countries. James and Antonia opened their home and their lives to the COTT team, including my youngest daughter, Kaile Laubua, who to this day speaks about the impact James and Antonia had on her. Antonia or “Smudge” as she is known was especially warm and welcoming to my daughter and the entire COTT team. The night we had diner at their apartment was one I will never forgot. John Plater was there as well and the banter between John, James, myself and the whole COTT crew was one I wish we had taped as the exchanges went from dark humor regarding our collective lives, to serious brainstorming about issues and initiatives to the political differences between Canada and the States. The sense of trust, brotherhood and sisterhood was so strong that I felt blessed to have had the opportunity to be present with our wonderful friends from Canada.
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Simply stated, James Kreppner was one of my personal heroes. His commitment, his strength and his amazing courage were clear beacons of light for Corey Dubin. Whenever I would get depressed or down about the physical struggle of coinfection, I would reflect on James, or just phone him up and have a good talk. One thing is for sure, thinking about James or speaking with him always made things a bit more possible. He had such a wonderful sense of who we all were and why we needed to work together for the greater good.
 
James possessed a strong intellect, a great sense of humor, and a deep and unwavering commitment to the global hemophilia community.
 
Antonia “Smudge” Swann, James’ loving and talented wife, authored the following poem. She is a poet, musician and loving soul mate to James. Also someone COTT and myself have had the honor of calling a friend and fellow traveler in the struggle for justice for our community. Smudge authored the following poem in honor of all the people struggling to survive the HIV/AIDS and HCV epidemics in the global hemophilia community.
 

Sick

I am sick of people dying

And of families always crying

Cause of other people’s lying

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Who will own up?

Be a grown up?

Finally man enough?

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Who will go to jail?

Tell the truthful tale

Ain't got enough bail

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When a sister stops the IV

To try to set her brother “free”

I know it still bothers me

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Another fun-er-al

A service full of bull

A swap of corpse for soul

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 “Dying with Dignity”

Seems like a joke to me

 Mine-bound eternally

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3-D kin become 2-D kin

Never again this sufferin’

Cut short a song about to begin

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Ultimate breach of trust

The methane did combust

Another one bites the dust

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Canary in the mine

Injected full of slime

Cut short before its time

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The story starts with precious red

Ends with too many people dead

Empty cage, white sheets on the bed

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The miners got away

Canaries just betrayed

Below the shaft they stayed

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Widows walk alone

Pulses turned to stone

Blood unwholesome

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 “Safest in the World” they said

Before they put the birds to bed

Still they sew their usual thread

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We’ve got nothin’ to loose

We already sing the blues

Cuz ones have now replaced twos

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Lawyers wasting time

Running from the crime

Justice past its prime

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Always facing pain and tears

Family members disappear

Death is always hoverin’ near

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You still do what you do

As if no one knew

The real meaning of truth

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How many souls have gone?

Prematurely withdrawn

‘Cause of what you did wrong!

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Empty court seats filled with ghosts

Each of them: a lethal dose

Watching trials that seem like jokes

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Heartless troops still march on

As if nothing’s gone wrong

Ever the same, sick, sad song

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A gassed-out coalmine now gone rotten

A lifeless bird lies at the bottom

An abandoned canary just forgotten

 

James Kreppner Presente’

      

 

 

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
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Attachment #1: Recent article on taxing health benefits

President Pivots on Taxing Benefits
Obama Is Willing to Consider Move to Gain Health Reform

By Ceci Connolly
Washington Post Staff Writer
Wednesday, June 3, 2009
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President Obama, in a pivot from some of his harshest campaign rhetoric, told Democratic senators yesterday that he is willing to consider taxing employer-sponsored health benefits to help pay for a broad expansion of coverage.
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Senate Finance Committee Chairman Max Baucus (D-Mont.) said Obama expressed a willingness to consider changing the existing tax exclusion. The decision would probably anger liberal supporters such as labor unions, but such a tax change would raise enormous sums of money as Congress and the White House are struggling to find the estimated $1.2 trillion needed to pay for health-care reform over the next decade.
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"Yeah, it's something that he might consider," Baucus told reporters after the meeting between Obama and Democratic lawmakers. "That was discussed. It's on the table." Obama had summoned about two dozen senators to the White House to keep up the pressure to enact a comprehensive health-care overhaul this year.
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White House officials moved quickly to clarify that taxing the health insurance provided by businesses is not Obama's first choice, but aides refused to rule out the possibility.
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"The president made it clear during the campaign that he has serious concerns about taxing health-care benefits, and he has introduced his own revenue proposal, which he reiterated in today's meeting," spokesman Reid Cherlin said.
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Obama instead urged senators to reconsider his proposal, which would raise federal revenue by reducing itemized deductions such as charitable contributions and mortgage payments for the wealthiest Americans, according to one adviser in the meeting. Obama included that idea in his budget, reporting that it would raise $317 billion over 10 years, a sizable "down payment" on the cost of health-care reform. But Congress immediately labeled the proposal a non-starter.
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Private-sector businesses spend about $518 billion a year on their workers' health insurance, benefits that are not taxed. If workers had to pay taxes on their health coverage, it would raise $246 billion in revenue each year, according to the congressional Joint Committee on Taxation.
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Tax treatment of employer-sponsored health care cuts across party lines: Prominent Republicans such as Sen. Judd Gregg (N.H.) support imposing a tax on certain health plans, while Democrats such as Sen. Sherrod Brown (Ohio) say that a tax would unfairly hurt middle-class workers with good benefits.
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Health analysts from across the political spectrum have pressed for changing the tax treatment, arguing in part that the exclusion provides the greatest tax relief to high-salaried workers with generous insurance plans.
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Last month, Baucus said he did not support eliminating the exclusion but was eyeing a benefit cap. Experts have outlined two likely approaches: taxing health benefits for workers above a certain income level; or taxing benefits over a certain value, perhaps $14,000 a year.
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Administration officials meeting with lobbyists in recent days have projected that a benefit cap might generate $35 billion a year, though Finance Committee staffers said the number could be much higher.
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Nevertheless, the issue represents treacherous politics for Obama, given his attacks on Sen. John McCain (R-Ariz.), who advocated a similar approach during the campaign.
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"For the first time in American history, he wants to tax your health benefits," Obama said in September. "Apparently, Senator McCain doesn't think it's enough that your health premiums have doubled. He thinks you should have to pay taxes on them, too."
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Strongly desiring to declare a health-care victory this year, Obama is now taking a more nuanced approach, aides said. "His style of leadership is to say, let's not get bogged down; let's keep moving forward," said one senior adviser who was in yesterday's meeting. "He's not ruling anybody's ideas out."
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Attachment #2: Coalition Letter to
Congressional Health Committee Chairs
 
May 22, 2009
 
Honorable Max Baucus
Chairman, Committee on Finance
219 Dirksen Senate Office Building
Washington, DC  20510

RE: “Expanding Health Care Coverage:  Proposals to Provide Affordable Coverage to All Americans”

Dear Mr. Chairman:

We sincerely appreciate your efforts to create reforms that will provide adequate, affordable health care for all Americans, and would like to take this opportunity to provide requested feedback on your May 14, 2009 options paper entitled, “Expanding Health Care Coverage:  Proposals to Provide Affordable Coverage to All Americans.”

We are writing on behalf of the nearly 30 million Americans with rare chronic diseases, whom we represent.  Your options paper has addressed several issues that are very critical for our constituents.  In particular, we applaud you for trying to eliminate rating based on pre-existing conditions.  It is especially crucial that individuals with rare chronic conditions have access to affordable coverage for all necessary care, regardless of any pre-existing condition.  Many rare chronic conditions are based on genetic disorders, which are by definition, “pre-existing.”  Insurers must not be permitted to deny coverage for a disease with which an individual is born and that may take years, or even decades, to diagnose. 

We are also extremely pleased and appreciative that the Committee included an option to eliminate limitations on benefits; we urge you to maintain your stance to ensure that plans cannot include lifetime limits on coverage or annual limits on any benefits.  Individuals with rare chronic diseases must not be impeded in accessing necessary health care nor should they be impoverished with unreasonable lifetime or annual limits on benefits and unreasonable out-of-pocket expenses.

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These reforms will help all Americans.  However, as you further consider comprehensive health care reform, we strongly urge you to address some of the individualized needs of those with rare chronic diseases, many of which are caused by known genetic defects.  These conditions present a particular challenge, as they often require very complex and specialized treatments, which are often very expensive.  Without timely, appropriate treatment, these individuals may develop complications resulting in unnecessary additional costs.  Providing individuals with rare chronic diseases with the treatments they need allows them greater opportunity to lead healthy lives and be productive members of society.  Appropriate treatment for these individuals includes access to specialized treatment.

We call upon all policymakers engaged in the current health care reform process to ensure that the system fully addresses the needs of all Americans including the specialized needs of individuals with rare chronic diseases.  If you have any questions or would like additional information, please contact Diane Dorman (202 258-6457 or ddorman@rarediseases.org) or Larry LaMotte (443-632-2552 or llamotte@primaryimmune.org).

Sincerely,


National Organization for Rare Disorders
GBS/CIDP Foundation International
Committee of Ten Thousand
Hemophilia Federation of America
Immune Deficiency Foundation
National Hemophilia Foundation
Platelet Disorder Support Association
 
Attachment #3: COTT Testimony at April ACBSA Mtg:
"Managing the Nation’s Blood System:
A Historical Perspective”
           
The history of the Advisory Committee on Blood Safety & Availability cannot be separated from the contamination of our nation’s blood supply with hepatitis and HIV/AIDS. In fact this committee is one of the positive outcomes emanating from the twin blood borne nightmares of HIV/AIDS and hepatitis C. It is a history steeped in the devastation of an entire American chronic disease community through HIV/AIDS tainted blood products.
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However, the HIV/AIDS contamination of the blood supply is not the real story, it is the result. The real story is the four-decade contamination of our nation’s blood supply with hepatitis; it is one of indifference, inaction and a serious lack of concern for the end users of blood, blood components and blood products.
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It is a story of pain and hopelessness while simultaneously being one of empowerment, dignity and the unwillingness of an entire disease community to go quietly into that dark night. 
               
As a community in crisis, we could have easily turned inward, falling into depression and inaction. However we took the opposite approach and began organizing the community to respond to the nightmare we found ourselves in. We identified the places we would have to impact our nation’s blood system to make the changes necessary to ensure that this never happens again.
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Our first interactions with the blood system represented another wake-up call for the hemophilia community. As if contracting two deadly viruses from our FDA approved clotting factor was not enough, we were confronted with a blood system in full defensive retreat. Our initial attempts to engage the blood system were met with indifference, inaction and, at times, outright hostility to our concerns and our anger at what had occurred.
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However, we held our ground and slowly but surely began to make progress in our engagement with the nation’s blood system and the federal government. We certainly communicated our anger at the colossal failure that we were the recipients of. We also communicated our willingness to roll up our sleeves and work with the federal government and the private sector to ensure that a failure of this magnitude did not occur again.
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We viewed ourselves as the “canaries in the coalmine” for America’s blood supply. In essence, hemophilia was the early warning radar for this nation’s blood system. The price we paid was far to high and the survivors continue to pay the price of America’s failure.
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In 1993, in response to COTT’s demands for a congressional investigation into the contamination of the blood supply, Senators, Kennedy of Massachusetts and Graham of Florida proposed a study by the National Academy of Sciences, Institute of Medicine.
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The IOM Study, “HIV and The Blood Supply, An Analysis In Crisis Decision making”, was published in July of 1995. It represented a critical first step in our quest to repair the American Blood System. The report detailed where and how the system failed and concluded with fourteen recommendations for the future.
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For the purpose of today’s discussion Recommendations 1 and 2 are of special importance. Recommendation 1 called on the Secretary of Health & Human Services, “To designate a Blood Safety Director, at the level of a deputy assistant secretary or higher, to be responsible for the federal government’s efforts to maintain the safety of the nation’s blood supply.”
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Recommendation 2 stated that, “The PHS should establish a Blood Safety Council to asses current and future threats to the blood supply, to propose strategies for overcoming these threats, to evaluate the response of the Public Health Service to these proposals, and to monitor the implementation of these strategies. The council should report to the Blood Safety Director. The council should also serve to alert scientists about the needs and opportunities for research to maximize the safety of blood and blood products. The Blood safety Council should take the lead to ensure the education of public health officials, clinicians, and the public about the nature of threats to our nation’s blood supply and the public health strategies for dealing with these threats.”
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The Blood Safety Council recommended by the IOM is what became the Advisory Committee On Blood Safety and Availability. The first two IOM recommendations are critical to ensuring the interagency coordination necessary to confront current and future threats to our nation’s blood supply. They also remain as critical today as they were when first published in 1995.
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Recommendation 12 stated that, when faced with a decision in which all options carry risk, especially if the amount of risk is uncertain, physicians and patients should take extra care to discuss a wide range of issues.”
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On this important recommendation the ACBSA has failed to address questions of physician and patient education regarding risk and how to view the uncertainty of that risk. In fact, the Committee has never substantively addressed the question of how physicians and patients cope with the ambiguity of risk and the management of that risk.
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Recommendation 14 stated that, “Voluntary organizations that make recommendations about using commercial products must avoid conflicts of interest, maintain independent judgment, and otherwise act so as to earn the confidence of the public and patients.”
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In this instance, the Committee has again failed to address the question of product recommendations and independence of those organizations making the recommendations. Conflict of interest is certainly alive and flourishing in the hemophilia community and other chronic disease communities as well.
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It is clear to COTT that the ACBSA sorely needs to revisit the IOM recommendations and ascertain where gaps exist and how the Committee can work to fill those gaps thereby contributing to a safer and more secure landscape for the end users of this nation’s blood supply.
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In the mid 1990s, the House of Representatives, Government Reform and Oversight Committee, undertook an investigation into the contamination of this nation’s blood supply with HIV/AIDS. COTT testified before the Subcommittee and what we said in October of 1996 remains relevant today and is worth quoting:
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“The HIV contamination of the blood supply is the result of regulatory failure and industry inaction. However it is a result and not the real story. The real story lies in three decades of hepatitis transmission through blood and blood products. It is the story of industry indifference and FDA unwillingness and/or inability to aggressively address hepatitis contamination of the nation’s blood supply.
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By 1974 the FDA clearly understood the dangers of transfusion associated hepatitis transmission. In that year the FDA Commissioner stated that, “approximately three thousand deaths and more than twenty thousand overt cases of illness have been estimated to have been caused by the transfusion of hepatitis carrying blood in this country annually”. On July 15, 1975 the FDA adopted new regulations regarding blood and blood products. Those rules called for the testing of all collected blood for the presence of hepatitis B surface antigen. The rules also mandated that any, “ blood, plasma or serum that is reactive when tested for hepatitis B surface antigen shall not be used in the manufacturing of injectable biologic products”.
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While the FDA was correct in imposing new regulations for blood and blood products, the enforcement of the regulation adopted was lax at best and in many cases non-existent. Bad blood continued to enter the system while large pools of collected plasma contaminated with hepatitis were fractionated to produce factor VIII and IX concentrates which were marketed for the treatment of hemophilia.”
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The AIDS/blood epidemic is one of the darkest chapters in the history of American medicine. It represents the worst iatrogenic medical disaster in the history of our nation.
               
What are the lessons to be learned from the 1970s and 1980s when so many were severely harmed by the contamination of our nation’s blood supply?
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First and foremost for the end users of the blood supply is to remember that “cost effectiveness” was the guidance for decisions regarding the blood supply and the reason hepatitis was not addressed as a core threat to those who depend on blood, blood components and blood products for their health and well-being.
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The precautionary principle flows from four important documents, adopted by the US House of Representatives, which together establish the basis for this important guidance:
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1. The Institute of Medicine Report, HIV and the Blood Supply, An Analysis In Crisis Decision Making;
2. DHHS Secretary Shalala’s sworn testimony before the House of Representatives, Government Reform and Oversight Committee in response to the IOM Report;
3. The House of Representatives, Government Reform and Oversight Committee Report, Protecting The Nation’s Blood Supply From Infectious Agents and The Need For New Standards To Meet New Threats, and
4. The House of Representatives, Government Reform and Oversight Committee Report, Hepatitis C; Silent Epidemic; Mute Public Health Response.
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The Committee of Ten Thousand is proud to have participated in the three  investigations listed and in one instance, the IOM Report, was the driving force in making it happen. We have been present in these deliberations since 1992 and COTT has always looked to the larger societal issues as they relate to the safety and efficacy of our nation’s blood supply.

It is also important to remember that ten thousand members of the hemophilia community were infected with HIV/AIDS, roughly eight thousand have died, many of them also co-infected with hepatitis C. In addition another twelve thousand individuals were infected with HIV/AIDS through transfusion -associated transmission.

Any discussion of abandoning the “Precautionary Principle” and returning to cost effectiveness is unacceptable to the survivors of the blood wars of the 1970s, 1980s, and 1990s. It leaves us with a foreboding sense of fear and déjà vu. Such a decision from our perspective foreshadows a reoccurrence of the nightmare of the 1970s, 19980s and 1990s for the hemophilia community.

At a time when sixty-five percent of America’s collected blood is done so under a Federal District Court Consent Decree, it is unfathomable to us that anyone in the blood system would even consider abandoning the Precautionary Principle.

We are also facing the first confirmed case of the blood transmission of variant CJD in a man with hemophilia in the United Kingdom. As a result the community is bracing for the potential US case that could occur. Yet that important issue is nowhere to be found at this meeting of the ACBSA. Here was a risk thought for years to be theoretical which is now very real for those of us who depend on blood products to remain healthy.

COTT has also repeatedly raised the issue of Source Plasma collection along the Texas/Mexico border and the potential safety risks posed by that collection. We have called for an expanded regulatory framework that addresses poverty and the lack of access to health care in donor populations. Yet the border collection issue has not been discussed or addressed by the ACBSA.


From our perspective this is not a time to look at cost effectiveness or comparative effectiveness when considering decisions regarding the safety of this nation’s blood and the ability of the federal government and the blood community to cope with serious and/or deadly threats to the blood supply.


Again we must remember that cost effectiveness drove critical decisions in the 1970s and 1980s by federal decision-making bodies where the end users, those that would shoulder the risk and the impact, were not represented in those forums and advisory committees. In fact, it took intense pressure from the Congress to ensure that all the stakeholders, especially those who shoulder the ongoing risk of depending on the blood supply, are represented on the decision-making bodies whose decisions can have such a devastating impact on the users of blood, blood components and blood products.


It is important to note that when cost effectiveness was the guidance, there was no calculation of the cost of a blood borne epidemic to the health care system. Why have we never calculated the cost to the tax payers of treating the ten thousand HIV infections in hemophilia alone, or the many Americans whose liver transplant was the direct result of transfusion transmitted hepatitis C? It is time we address the real cost of four decades of transfusion associated hepatitis C.


COTT rejects any policy landscape that places our faith only in technology and the ability of our science to address these real and potential threats to the end users of the blood supply. It is the confluence of good science, strong policy discussion and development, and a healthy dose of caution when the issue is the safety of our nation’s most precious resource, blood.


We remain concerned about the ACBSA’s lack of contact with its most important client, the Secretary of Health & Human Services. Over the last eight years the ACBSA has become ineffective, in part, due to its lack of relevancy to the DHHS Secretary. With the new administration it is time to reconnect this critical committee with its most relevant client. In the absence of that connection we have watched the ACBSA become marginalized and ineffective at a time when we are faced with a plethora of issues and questions regarding the management of our nation’s blood system. We must renew our efforts to change this dangerous situation and create the interagency coordination that is critical to the safety and availability of our nation’s blood supply.


We are also deeply concerned about the new ACBSA’s roster and the dominance of the blood banking community at the expense of other stakeholders such as end users. We will not sit idly by while the user communities are marginalized from the very advisory committee COTT was instrumental in establishing.


We, who shouldered the risk and the impact HIV/AIDS and hepatitis C in our blood supply, cannot and will not dishonor the eight thousand members of our community who died as a result of the preventable blood borne epidemics of HIV/AIDS and hepatitis C in the hemophilia community. And what of the young parents in the community who depend on the federal government and the blood community to protect the safety of the products they are infusing into their sons and daughters.


We are not prepared to watch as this or any other federal advisory committee abandons the Precautionary Principle in favor of cost effectiveness or comparative effectiveness. We remain the dwindling survivors of the twin blood borne nightmares of HIV/AIDS and hepatitis C. We understand that cost effectiveness can and did equal widespread suffering and death for our community. We do not intend to experience a repeat performance due to the lack of concern for those that are the canaries in the coalmine. At the recent meeting of the FDA CBER, Blood Products Advisory Committee, we again learned that the blood banking community appears to be unconcerned about reestablishing the trust of those who depend on the blood supply due to chronic disease such as hemophilia.


We remember, and will never forget that it was the AABB-NIH Transfusion Transmitted Disease Committee that opposed the adoption of the HBV core antibody test as a surrogate for HIV early on in the epidemic. We do not forget that it was the American Red Cross and the blood banking community that resisted the immediate implementation of a robust national donor screening and testing program that could have greatly reduced the impact of blood borne HIV/AIDS. We understand that cost effectiveness ensured that three generations of persons with hemophilia would face the ravages of HIV/AIDS and hepatitis C.


In conclusion, any attempts to abandon the Precautionary Principle will be meet with widespread opposition from end user communities. We also believe that the four critical documents cited above should be required reading for any member of the ACBSA as we will not allow the blood community or the federal government to forget what occurred in the hemophilia community, widespread suffering and death as a result of the failure of the federal regulatory system and the blood community to protect the end users of blood, blood components and blood products.


Attachment #4: COTT Testimony at June FDA TSEAC Meeting

On February 17th of this year, it was reported in the British press that an older man with hemophilia, who died of unrelated causes, upon autopsy, presented evidence of variant Creutzfeldt-Jakob Disease in his spleen. He had received at least one lot of United Kingdom produced clotting factor which contained the plasma from a donor who had subsequently developed vCJD.

These revelations sent a shock wave through the hemophilia community in the UK as well as here in the United States where CJD and vCJD transmission though blood were still considered a theoretical risk. By the end of February it appeared as if the theoretical risk -- the blood borne transmission of vCJD through human clotting factor -- had become a known, actual risk. The Committee of Ten Thousand asked FDA CBER for a teleconference on the matter, during which we asked as well for a meeting of this advisory committee (which had not met since December of 2006).

We want to remind the Committee that this Sunday June 14th is the World Health Organization’s World Blood Donor Day. The global theme for 2009 as articulated by WHO is: “placing a renewed emphasis on improving the safety and efficacy of the world’s blood supply.” We certainly concur with WHO’s efforts to raise safety and efficacy. Yet, we remain troubled by the British revelations as well as the propensity of the American blood community to have a short historical memory and, at times, a perspective still needing to be informed by the events of the last three decades.  We remain for example deeply concerned about source plasma collection on the US-Mexico border, which raises both safety and ethical questions and concerns. The inability of the American Red Cross to get its house in order and move beyond the sixteen year old, multi-million-dollar-fine-laden Consent Decree it has been operating under between the Federal District Court, the FDA and the ARC is shocking considering that this organization is responsible for collection of over forty percent of the whole blood in the US annually. Now we add to the mix the vCJD case being discussed today.


We must seek to be more and more vigilant in addressing both known and unknown threats, despite the progress made in safety of the blood supply.


While donor health is a high priority for the blood system, recipient/end user health and trust must also be a high priority. Recent meetings of the FDA Blood Products Advisory Committee and the DHHS Advisory Committee on Blood Safety & Availability included discussions of donor health and safety, and transparency in the blood system. Unfortunately, as often before, end users were not a priority in terms of either well being or trust. If the system is so safe then why do we still lack a more humane and rational policy approach to failure. A blood injury act or structure represents good public policy, a more humane and compassionate approach to the ultimate risk shouldered by the end users of the blood supply, especially those chronic disease communities that regularly depend on the blood supply to maintain their health and wellness.


Such a policy also makes good economic sense if we consider the real costs of the AIDS/Blood and hepatitis blood borne epidemics that have ravaged certain disease communities. COTT has been calling for a Blood Injury Act/structure since the early 1990s and we will continue to do so., especially in a climate where we are consistently being told how minimal the risks are. While we understand risk and the ambiguity of living with that risk when one depends on the blood supply, we are still looking for the blood community and the federal government to step up to the plate and substantively address that risk by ensuring that those who are harmed by blood borne pathogens with be taken care of and not left to fend for themselves as the hemophilia community was in the wake of the AIDS/blood and hepatitis C epidemics. For the hemophilia community, this is at the core of our perspective. If the risk is as low as is stated, then why have the blood community and the federal government neglected to propose a structure to compensate those harmed?


Consider the last decade of FDA regulation of CJD issues.  After building up a substantial number of reasons for deferral of potential blood donors with regard to relationship with a person with CJD, including growth hormone, familial risk, etc., HHS in 1999 all at once eliminated all deferrals related to CJD not specifically tied to vCJD.  The studies supporting this action must have clearly shown that while vCJD is transmissible, any other kind of CJD is not. As new strains emerge, and the sCJD voice community expresses deeper doubt that classical is not transmissible, the action seems a bit precipitous – and definitely in the direction AWAY from safety.


Also, after reviewing a raft of industry studies that show something like a five log reduction of prions in fractionation, prior to having any clinical indication as to what constitutes a SAFE level of prions, the agency exempted numerous countries from the vCJD-driven blood donor deferrals based on travel and intervals of residence, saying to all, go ahead and collect plasma, we know that whatever infection there is will be negated in the processing.  


Taking comfort from these same studies, industry studies, none of which have completely replicated the fractionation process, instead using a spike amount of a surrogate TSE, the agency has developed a risk management model that allegedly demonstrates, that America's blood is safe from this TSEs.
 
Does the FDA computer-driven model factor in (e.g. compensates for) the USDA's poor levels of surveillance for BSE in the US?  Does it factor in the numerous strains of CJD other than vCJD and sporadic/familial CJD? Some may be more infectious than others.  Evidence given at the last meeting of this committee, two-and-one-half years ago, suggests it has not. Nevertheless, the results were in, the answer was clear, the matter was closed.
 
We still do not know the relationship between prion reduction and risk reduction.  A simple point, this is fundamental to risk analysis.  The agency’s actions, taken in the face of very little field data, is an example of how not to do public health policy:  the precautionary principle in such cases dictates that the only change allowable absent better data is a change to INCREASE safety.

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Consider now the families of persons with hemophilia in the United Kingdom.  For years they have been seeking knowledge on what batches or lots of plasma-derived factor that they consumed years previously, included blood or plasma from a donor who subsequently turned out to contract vCJD.  There has been little peace in this community while this search has gone on; some of the information was withheld from them for years. 
 
It is this roiled community, 4000 households. that in 2004 received a standard letter from the government: you are at high risk, you must tell your doctors, dentists, etcetera this fact, you must take precautions against further spread of the disease.
 
Not one word about how the public health leadership in the country has provided for this community's care, starting with the date of the letter.  It's like the early days of AIDS: since there's no treatment, and its universally fatal, you should tidy up your affairs and wait.
 
Now comes word of ONE case of prions discovered in a person with hemophilia, not at a symptomatic level, but also not in the normal digestive tract as would be the typical case with beef-related disease.  Based on these facts alone the conclusion announced was that it was likely due to infusion of plasma-derived factor over ten years previously, from a lot a donor to which subsequently contracted the disease.
 
This was in February.  Today is June 12th.  No expanded explanation, clarification, or other augmented report of any kind has been issued since, and the hemophilia community worldwide has been on the edge of its seat to learn what implications this case might have for them.  Oh, we understand a description of the case is in press at a medical journal for publication this summer, but community organizations generally do not have the resources to subscribe to a broad range of such publications and thus may not see it in a timely manner.
 
Why is not the UK Health Protection Agency issuing at least monthly updates on the circumstances of this find, if not planning a large and far more widely cast report of its own? Why in fact has this not already been done?
 
We urge the FDA to learn from the UK way of handling the hemophilia population there, and instead be a ready source, for those at higher risk and for the general public, of ample information including on the strains, of the disease, on the changing size and other characteristics of the population with CJD in the US, of a primer on how USDA conducted its surveillance, and how a more developed methodology would have produced more credible results.
 
Our other specific requests are as follows:
> Recommend that Commissioner Hamburg request of Secretary Sibelius that the NIH research agenda on human TSEs and their relationship to animal TSEs be re-activated. This should include study of the several strains of CJD now recognized, their evolution and any contagion risk; it should also specifically study the rapidity, both intra- and interspecies, of transmission in all known TSEs. A particular focus of this work should be the transmissibility of different TSEs in humans, particularly through blood.


> The Committee should also petition the Commissioner to request that CDC augment its surveillance system for Hemophilia Treatment Centers (HTCs) around the country, to include a comprehensive in-service training program for all HTC staff with patient contact, particularly physicians, on human TSEs, particularly on the differences between CJD and vCJD. Included in the training should be strong encouragement that families request autopsy in any HTC patient death involving dementia, other neurological symptoms, or otherwise possibly associated with TSE, for purposes of positive diagnosis; at present post-mortem determination offers the only evidence for positive diagnosis of CJDs.


> CBER should prepare a report for the Commissioner on the adequacy of the USDA BSE surveillance program, including each of its phases, during the last eight years.  If the finding is that the methodology and execution of the field phases of the process may have failed to find and include all cases of BSE, the Commissioner should request of the Secretary an inter-Departmental memo to Secretary Vilsack of Agriculture specifically identifying the points made, and asking that the surveillance program be re-activated at a higher level of investment than previously, to aid in properly identifying a contagion risk that is jeopardizes human health as well as animal health.

> In terms of surveillance of human TSEs, we strongly recommend that the Committee petition the Commissioner to request that CDC hereafter require reporting of any human TSE – vCJD, CJD of any other strain, and, should it develop, TSEs from deer or other vectors.  We understand that states voluntarily submit reports to CDC for its tabulations, but we feel it is derelict for there not to have been national collection and reporting on these diseases to date, and that this must be rectified.

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We have long followed these diseases, and appreciate the FDA’s forthright attempts to track, research, and develop preventive strategies around them.  We trust that will continue.  Further, as can be seen from the nature of some of our recommendations, there is a lack of inter-Departmental coordination, if not White House Task Force status, on the diseases.  The fact that the core of those ill are cases that come to people from the food chain, complicates the regulatory and public health issues, some would say almost to a standstill. This committee alone is in a position to call out to the key players involved to put in place inter-organizational oversight structure, to break this logjam.

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Attachment #5: COTT Presentation at June PPTA Forum:
“Confronting the Challenges of the 21st Century
in a New Economic Paradigm”
We would like to dedicate this talk to the memory of James Kreppner, recently deceased.  James was a longstanding President of the Canadian Hemophilia Society, a good friend to COTT, and a member of the panel charged with reorganizing the Canadian blood system in the wake of the Krever Report on contamination.  He will be deeply missed.


The Committee of Ten Thousand is pleased to be participating in the 2009 Plasma Protein Forum Surveillance Panel. As always, COTT is appreciative of the opportunity to present our perspective as one of the end user communities of this nation’s blood supply as well as being an organization born of the AIDS Blood and hepatitis C epidemics of the 1970s and 1980s. COTT has always viewed itself as an important grass-roots organization, representing end users of the blood supply. While our core constituency is the HIV/AIDS and HCV infected hemophilia community, our projects and initiatives have also been relevant for the larger bleeding disorders community, as well as all the chronic disease communities who depend on a safe and available blood supply.

The Committee of Ten Thousand views surveillance and adverse events reporting as inextricably interwoven with the larger issues of safety and economics. For us, it cannot be separated from the recent discussion of safety and economics that occurred before the DHHS Advisory Committee On Blood Safety and Availability.

In a time of declining health care resources, amid an ongoing economic crisis, how do we construct the safety equation into the future and how do we structure the surveillance and adverse event reporting necessary to support safety through identifying adverse events and monitoring for threats to us, the end users of the nation’s blood supply?
Being members of the HIV/AIDS and HCV infected hemophilia community has given us a unique view of risk associated with the blood supply and living with the ambiguity of that risk. We, the end users, shoulder the ultimate risk, the potential harm to life and well being when a failure occurs in the management of the blood supply. For ten thousand persons with hemophilia, and roughly twelve to fifteen thousand people who contracted transfusion associated HIV/AIDS, that failure of course did occur, and we were left with the ultimate risk and the ambiguity of living with HIV/AIDS, which at the time was tantamount to a death sentence.

When considering the economics of the safety equation, you never see the real costs of failure. What are the true societal cost of treating those infected with HIV/AIDS and hepatitis C acquired through blood, blood components and blood products? The true costs of failure should inform our decisions about safety and the resources and structures necessary to support that safety. COTT has been involved in the blood supply since 1992 and we have never, in that seventeen years, seen the real cost ever presented in any economic calculations associated with the safety of our nation’s blood, blood components and blood products.

In hemophilia we are facing challenges and threats to our care rooted in the economic crisis our nation is facing. With so many states in deficit, draconian cuts are proposed in many state’s health care spending. Greater barriers to state program eligibility are being proposed in California and other states. In numerous state capitals, the bleeding disorders community, along with other chronic disease communities, is facing deep cuts in access to care, and in the quality of care.

How we use our declining health care resources will greatly impact the success and efficacy of our combined efforts in the blood community. Surveillance and adverse event reporting are critical components of the safety equation, however, COTT has serious concerns regarding our approach to surveillance and adverse event reporting systems as they are currently structured.

Why do we continue to need multiple adverse event tracking and surveillance structures? The American Red Cross, The American Association of Blood Banks, Americas Blood Centers and the federal government’s AERS/MedWatch, as well as the new Sentinel system between FDA and the Center For Medicaid and Medicare utilizing surveillance of CMS patient data bases, are all designed to provide adverse event reporting and surveillance of the nation’s blood supply. Yet in order to attain the desired outcomes, these systems have to be able to communicate with each other. It is counterintuitive to create multiple systems to attain the same national objective given the substantial cost associated with creating the software to enable these different systems to communicate with each other.

The reason for the existence of multiple adverse event tracking and reporting systems is that the cornerstone system, the first and most official, the FDA’s AERS./ MedWatch system, was never implemented as a mandatory system.  As a voluntary system, it has huge holes.  So we are faced with multiple systems.  Is there something to be gained by having multiple systems?  Do we, as a nation, continue to have the luxury of multiple systems and is this the most efficient and effective approach to adverse event reporting and surveillance? For COTT, this is not the most efficient and effective approach to these critical safety support functions. In fact, we view it as inefficient, at times duplicative, and certainly not an effective method of utilizing precious, and limited, national health care resources.

Rather than designing and implementing a comprehensive, national, adverse event reporting and surveillance system that is reflective of the needs of the entire American blood system, we have multiple systems that are more representative of the agencies/organizations that design and operate their respective systems. As a result, our surveillance and adverse reporting systems are not rooted in the needs, experiences and history of the entire American blood system. Worst case, the different systems are the result of the ongoing turf wars between ARC, AABB, ABC and the federal government. How is this defensible in the context of the efficiencies and efficacy of any one of the surveillance and adverse reporting systems? It becomes even less defensible when we add to this equation the economic crisis and its impact on a health care system already in distress.

Americans view our privatized medical system as engendering innovation, creativity and higher efficiencies as a result of competition on the ground. While competition can contribute to more positive outcomes in health care delivery, it is not conducive to the creation of a more efficient system in the arena of adverse events reporting and surveillance of the blood supply. In fact, it is a barrier to raising efficiencies and creating a streamlined national structure that provides substantive surveillance and timely adverse event reporting for our nation’s blood supply.

At a time when the blood community is consistently raising the issue of costs, how do they justify what COTT believes is an unreasonably expensive and inefficient approach to surveillance and adverse event reporting?

The Committee of Ten Thousand continues to call for mandatory reporting in the context of adverse event reporting. For us, it remains inconceivable that the United States would allow the continuance of a voluntary reporting structure for adverse events. How do we ensure any degree of reporting in a voluntary environment when the majority of the medical community remains unaware of AERS/MedWatch and how to use it? If the objective is, in fact, to ensure timely reporting of adverse events associated with the blood supply, then from an end users perspective, this is also counterintuitive. We have yet to hear any convincing arguments that would lead us to support the continuance of a voluntary reporting environment.

From where we sit, the concept of surveillance includes but is not limited to adverse event reporting. We are also concerned about another area of reporting, that concerning emerging pathogens, which we cannot at this stage say is divorced from adverse event reporting:  specific reporting regarding certain blood borne or potentially blood borne pathogens such as variant Creutzfeldt-Jakob Disease. Variant CJD is not currently a mandatorily reportable disease. Given the United Kingdom case, revealed in February of this year, vCJD transmission through blood has moved from the theoretical to the probable. In this case an older man with hemophilia, who died of unrelated causes, upon autopsy presented evidence of vCJD in his spleen. He did receive UK manufactured factor concentrates containing the plasma of a donor who was later found to have contracted variant CJD. COTT would expand the list of diseases required to report to include vCJD and others, such as Chagas, also a known threat to the safety of the blood supply.
               
In short, the absence of one, national, unitary and mandatory adverse events reporting and surveillance system, proven so effective in other countries, guarantees that in the US such reporting will remain partial, incomplete, and subject to the competing interests and objectives of the agencies/organizations that design and operate the different systems.
.
It is imperative that we move to a national, unitary, and mandatory system for surveillance and adverse event reporting. If we are to face the challenges and threats of the 21st century, we must have the courage, sense of national mission, and responsibility to future generations to put our individualism, our differences and our fears in the proper perspective and move forward, with a sense of purpose as one nation and one national blood supply.  For COTT, we are at a crossroads in terms of the future direction of our nation’s blood system and the safety and efficacy of that system.
.
.

Attachment #6: Recent FDA Enforcement Report excerpts

March 18
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0384-09
CODE
Units: 3404778, 3416050
RECALLING FIRM/MANUFACTURER
Southeastern Community Blood Center, Tallahassee, FL, by e-mail on May 1, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0504-09
CODE
Unit: 1678567 (split unit)
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by facsimile on July 14, 2008. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the cytomegalovirus (CMV) but were collected from a donor who previously tested positive for CMV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0557-09
CODE
Unit: 7028052
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, Inc., Long Island City, NY, by telephone and facsimile on July 18, 2007.
Manufacturer: New York Blood Center, Inc., Westbury, NY. Firm initiated recall is complete.
REASON
Blood product, which was possibly contaminated with Propionibacterium acnes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0572-09
CODE
Unit: 9756286
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on June 23, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to at increased risk for variant Creutzfeldt - Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0584-09
CODE
Unit: Y54293
RECALLING FIRM/MANUFACTURER
Virginia Blood Service, Inc., Richmond, VA, by letter dated February 20, 2008. Firm initiated recall is complete.
REASON
Blood product, incorrectly labeled as S-antigen negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0585-09;
b) Fresh Frozen Plasma, Recall # B-0856-09
CODE
a) and b) Unit: KS75939
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Sterling, VA, by letter dated July 21, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a body piercing within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0434-09
CODE
Unit: 72F369663
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by fax on April 18, 2008. Firm initiated recall is complete.
REASON
Blood product, processed from Whole Blood more than 8 hours after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Cryoprecipitated AHF, Recall # B-0552-09
CODE
Unit: 040GT62581
RECALLING FIRM/MANUFACTURER
American National Red Cross Heart of America Region, Peoria, IL, by telephone on July 25, 2008 and follow up letter dated August 22, 2008 and. Firm initiated recall is complete.
REASON
Blood product, stored at an unacceptable temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT
Source Plasma, Recall # B-0554-09
CODE
Units: 363026528, 36025409, 363023783, 363023443, 363023005, 363021567, 363025014, 363024089, 363020712, 363020282, 363021171, 363018914, 363017946, 363017245, 363016390, 363014703, 363014255, 363013716, 363013057, 363012436, 363012092, 363003589, 363002661, 363000713, I74061562, I74061285, I74054258
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Fort Worth, TX, by facsimile on November 8, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for high-risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
NC
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0569-09
CODE
Unit: 22FK96652
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by facsimile on July 29, 2008. Firm initiated recall is complete.
REASON
Blood product, which was Co(b+) antigen positive but labeled as Co(b-) antigen negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
__________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0570-09
CODE
Units: 22GG08156, 22LC54797, and 22KZ67206
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by facsimile on August 19, 2008. Firm initiated recall is complete.
REASON
Blood products, which were Cw(+) antigen positive but labeled as Cw(-) antigen negative, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
PA, NJ
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0571-09
CODE
Unit: 9756286
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on June 23, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to at increased risk for variant Creutzfeldt - Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
March 25
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0559-09
CODE
Units: 9954342 Parts 1, 2, and 3
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on November 13, 2007. Firm initiated recall is complete.
REASON
Blood products, which failed to meet the minimum product specifications for a 7 day platelet pheresis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0592-09
CODE
Unit: 71R431990
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center – Montgomery Region, Montgomery, AL, by facsimile on November 17, 2005. Firm initiated recall is complete.
REASON
Blood product, which was quarantined subsequent to receiving information regarding a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0602-09
CODE
Unit: 9916926
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on December 11, 2007. Firm initiated recall is complete.
REASON
Blood product, which did not meet the platelet pH QC specification, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Fresh Frozen Plasma (Apheresis), Recall # B-0607-09
CODE
Unit numbers: W085608000848, W084908001328, GY05499, FL32961, FL32808, LQ16296, FL32291, KE88444, KE88374, KE88373, GC08553, LT29480, LT29494, LT27858, LT27731, LN13761, LN13762, LT27356, LT06821, LT08128, LQ03964, LE03038, LQ03330, LQ04622, LT09813, LT10667, LQ05519, LT11607, LE04429, LQ06014, LE04833, LE04340, LE05153, LT14117, LE06289, LQ08004, LE05995, LT09877, LT09875, LE04063, LE04019, LE07500, LE07131, LS03217, LN09104, LT18638, LT18263, LT18067, LN08552, LE06426, LE06389, LT17248, and LQ03301.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by fax on July 11, 2008. Firm initiated recall is complete.
REASON
Blood products, processed without documentation of freezing time, were distributed.
VOLUME OF PRODUCT IN COMMERCE
53 units
DISTRIBUTION
PA
___________________________________
PRODUCT
Granulocytes Pheresis, Recall # B-0611-09
CODE
Unit: LH69577
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by telephone and facsimile on March 6, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0614-09
CODE
Unit: GR74669
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by electronic notification on August 24, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
a) Platelets Pheresis Leukocytes Reduced, Recall # B-0615-09;
b) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0616-09;
CODE
a) and b) Unit: 9912583
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on January 15, 2008. For, initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Propionibacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0632-09
CODE
Unit: 9866768 Part 1 and Part 2
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on October 20, 2007. Firm initiated recall is complete.
REASON
Blood products, which failed to meet the minimum product specifications for a 7 day platelet pheresis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0484-09
CODE
Units: 22FC40024, 22KY94833
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by letter dated October 22, 2007. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for red blood cell antigens, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0590-09
CODE
Unit: 18GQ19451
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI, by telephone on June 30, 2006 and by letter on July 7, 2006. Firm initiated recall is complete.
REASON
Blood product, which failed to meet the minimum specification for percent red blood cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0591-09
CODE
Unit: 71R431990
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center – Montgomery Region, Montgomery, AL, by facsimile on November 17, 2005. Firm initiated recall is complete.
REASON
Blood product, which was quarantined subsequent to receiving information regarding a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0593-09
CODE
Unit: 13X15531
RECALLING FIRM/MANUFACTURER
American Red Cross Southeastern Michigan Region, Detroit, MI, by telephone on October 11, 2006. Firm initiated recall is complete.
REASON
Blood product, which was exposed to unacceptable temperature during storage, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
April 1
___________________________________
PRODUCT
Source Plasma, Recall # B-0419-09
CODE
Units: GZ058579, GZ058265, GZ057836, GZ057674, GZ057102, GZ056889, GZ056492, GZ055913, GZ054841 and GZ053767
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Gary , IN , by fax on June 17, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0487-09
CODE
Unit: 53FL50346
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake and Potomac Region, Baltimore , MD , by telephone on August 21, 2008 followed by a letter dated August 27, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
_________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0582-09
CODE
Unit: 53FL58806
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake and Potomac Region, Baltimore , MD , by telephone on January 3, 2008 followed by a letter dated January 4, 2008. Firm initiated recall is complete.
REASON
Blood product, which was labeled as JK(b-), but was collected from a donor who subsequently tested JK(b+), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0583-09
CODE
Unit: 53FC70564
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake and Potomac Region, Baltimore , MD , by telephone on March 14, 2008 followed by a letter dated March 21, 2008. Firm initiated recall is complete.
REASON
Blood product, which was labeled as negative for the Fyb antigen, but was collected from a donor who subsequently tested positive for Fyb antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0617-09
CODE
Unit: 13FV95107 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
American Red Cross Southeastern Michigan Region, Detroit , MI , by telephone on July 14, 2008. Firm initiated recall is complete.
REASON
Blood products, which did not have quality control testing performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI
___________________________________
PRODUCT
a) Cryoprecipitated AHF, Recall # B-0620-09;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0621-09;
c) Platelets Pheresis Leukocytes Reduced, Recall # B-0622-09;
d) Recovered Plasma, Recall # B-0623-09
CODE
a), b), d) Unit: FQ90481 ;
c) FQ89249, FQ87227, FQ86353
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee , WI , by facsimile or electronic notification on April 10, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of sexual contact with an individual who lived in or immigrated from an HIV Group O risk area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
WI, TX, Switzerland
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0627-09
CODE
Unit: 6045864
RECALLING FIRM/MANUFACTURER
Blood Bank of Delmarva, Inc., Newark , DE , by letter dated August 18, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was previously deferred for testing positive for the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0628-09
b) Recovered Plasma, Recall # B-0629-09;
c) Fresh Frozen Plasma, Recall # B-0630-09
CODE
a) Units: 3202233, 3123605, 1857983, 1857985, 1857986, 1857981, 2318524, 3875140, 2321331, 4374545, 4372495, 4375557, 4763990;
 
b) Units: 1857986, 1857983, 1857981, 2318524, 3875140, 2321331, 4374545, 4763990, 3202233;
 
c) Unit: 1857985
RECALLING FIRM/MANUFACTURER
Indiana Blood Center , Indianapolis , IN , by telephone on July 30, 2008 or electronic notification on September 2, 2008. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for viral markers, were distributed.
VOLUME OF PRODUCT IN COMMERCE
23 units
DISTRIBUTION
IN
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0650-09
CODE
Unit: 13FP54357
RECALLING FIRM/MANUFACTURER
American Red Cross Southeastern Michigan Region, Detroit , MI , by telephone on August 1, 2008 and follow-up letter on August 25, 2008. Firm initiated recall is complete.
REASON
Blood product, for which Quality Control was not performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0659-09;
b) Fresh Frozen Plasma, Recall # B-0660-09;
c) Platelets, Recall # B-0661-09
CODE
a) and b) Units: KX07877; KX05639;
c) KX05639
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center , Memphis , TN , by letter beginning July 10, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
TN
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0684-09;
b) Recovered Plasma, Recall # B-0685-09
CODE
a) and b) Units: 6165539, 6184317
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center , San Antonio , TX , by fax and e-mail on November 25, 2008 and as follow-up by fax on February 5, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with risk factors for vCJD, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TX, Austria
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0686-09;
b) Cryoprecipitated AHF, Recall # B-0687-09
CODE
a) and b) Unit: 6176273
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center , San Antonio , TX , by fax on November 24, 2008 and December 2, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who disclosed taking Evista, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0631-09
CODE
Units: 4375557, 3123605
RECALLING FIRM/MANUFACTURER
Indiana Blood Center , Indianapolis , IN , by telephone on July 30, 2008 or electronic notification on September 2, 2008. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for viral markers, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Washed, Recall # B-0651-09
CODE
Units: Q64761, Y13712, F25713 and F70974
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers , Grand Rapids , MI , by fax on August 11, 2008 or September 8, 2008. Firm initiated recall is complete.
REASON
Washed red cells, manufactured with an incorrect saline solution, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
MI
___________________________________
April 29
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0761-09;
b) Recovered Plasma, Recall # B-0762-09
CODE
a) and b) Unit: 30GY76950
RECALLING FIRM/MANUFACTURER
American Red Cross, Northeastern, Ashley, PA, by telephone on November 19, 2008 and by letter dated November 21, 2008. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the hepatitis C virus (HCV), but were collected from a donor who was previously deferred for testing positive for HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, CT
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0767-09;
b) Plasma Frozen, Recall # B-0768-09
CODE
a) and b) Unit: W0415080155477
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock Center, Lubbock, TX, by telephone and facsimile on November 25, 2008 and by letter dated January 2, 2009. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis but were collected from a donor who was previously tested positive for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0769-09
CODE
Unit: 6584251
RECALLING FIRM/MANUFACTURER
Carter BloodCare/ WE & Lela 1 Stewart Blood Center, Inc., Tyler, TX, by letter dated March 17, 2009 and by telephone on March 27, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0772-09
CODE
Unit: 72J230806
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by Fax on January 6, 2009. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0775-09
CODE
Unit: 3562325
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by fax on March 12, 2009 and by e-mail on March 17, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS
___________________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-0777-09;
b) Red Blood Cells, Recall # B-0778-09
CODE
a) and b) Unit: 7019457
RECALLING FIRM/MANUFACTURER
HemaCare, Corp., Van Nuys, CA, by telephone and letter dated February 19, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0798-09;
b) Recovered Plasma, Recall # B-0799-09
CODE
a) and b) Unit: R45567
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Saginaw, MI, by fax and e-mail on October 22, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI and Switzerland
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0802-09;
b) Fresh Frozen Plasma, Recall # B-0803-09
CODE
a) and b) Unit: 3092369
RECALLING FIRM/MANUFACTURER
Community Blood Center, Inc., Appleton, WI, by letter dated December 5, 2008. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV-1/2), but were collected from a donor who previously tested repeat reactive for anti-HIV-1/2, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI, MI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0811-09
CODE
Unit: 2914694
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone and letter dated May 30, 2008. Firm initiated recall is complete.
REASON
Blood processed from a low volume unit of whole blood, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0814-09
CODE
Unit: Q38595
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Saginaw, MI, by fax on October 31, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
Red Blood Cells Irradiated, Recall # B-0817-09
CODE
Units: W067108024260, W067108024400
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by fax on September 12, 2008. Firm initiated recall is complete.
REASON
Blood products, labeled “leukoreduced”, but which had not undergone leukoreduction, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0765-09
CODE
Units: 21FP46089, 21LP01219, 21KT47258
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland, OR, by facsimile on November 7, 2008. Firm initiated recall is complete.
REASON
Blood products, for which the documentation of the time returned to controlled storage following irradiation was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
WA, OR
___________________________________
PRODUCT
Platelets Pooled Leukocytes Reduced, Recall # B-0771-09
CODE
Units: Y24712; Y24716; Y24715; Y24714
RECALLING FIRM/MANUFACTURER
Community Blood Center of Carolinas, Charlotte, NC, by telephone and fax on January 12, 2009 and follow-up e-mail on February 3, 2009. Firm initiated recall is complete.
REASON
Blood products, prepared from whole blood units stored at an unacceptable temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NC
_____________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0773-09;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0774-09
CODE
a) Unit: 4775004;
b) Unit: 2037777
RECALLING FIRM/MANUFACTURER
Indiana Blood Center, Indianapolis, IN, by telephone on July 17, 2006 and July 28, 20008. Firm initiated recall is complete.
REASON
Blood products, manufactured without additive solution, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IN
___________________________________
PRODUCT
a) Plasma Cryoprecipitate Reduced, Recall # B-0800-09;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0801-09
CODE
a) and b) Unit: F75554
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, MI, by facsimile on December 22, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the drug Celebrex at the time of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI
___________________________________
May 6
___________________________________
PRODUCT
Cryoprecipitated AHF, Recall # B-0738-09
CODE
Units: 0392938, 0338566, 0392951, 0392945, 0339544, 0392936, 0338548, 0392935, 0395688, 0338577, 0338554
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on October 11, 2007 and by letter on October 17, 2007. Firm initiated recall is complete.
REASON
Blood products, which were not manufactured in accordance to current Good Manufacturing Practices, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
LA, AL
___________________________________
PRODUCT
Cryoprecipitated AHF, Recall # B-0740-09
CODE
Units: 0355154, 0402207, 0409669, 0403795, 0405760, 0402211, 0355537, 0409667, 0406140, 0403532, 0403785
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on October 11, 2007 and by letter on October 17, 2007. Firm initiated recall is complete.
REASON
Blood products, which were not manufactured in accordance to current Good Manufacturing Practices, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
LA
___________________________________
PRODUCT
Source Plasma, Recall # B-0820-09
CODE
Units: TQ058060, TQ057525
RECALLING FIRM/MANUFACTURER
IBBI dba Knoxville Plasma Corp., Knoxville, TN, by fax on January 7, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma, Recall # B-0821-09
CODE
Units: 08KWIB1576, 08KWIB1537
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank, Inc., WI, Kenosha, WI, by fax on January 3, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0827-09;
b) Fresh Frozen Plasma, Recall # B-0828-09
CODE
a) and b) Units: 72J504140
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on December 29, 2008. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL


__________________________________
PRODUCT
Source Plasma, Recall # B-0832-09
CODE
Units: 08KWIB8683, 08KWIB7552, 08KWIB7387
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank, Inc. WI, Kenosha, WI, by facsimile on January 15, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who lived in an area considered at risk for HIV-Group O, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma, Recall # B-0833-09
CODE
Units: 2080234758, 2080230887, 2080230638, 2080229690, 2080229080
RECALLING FIRM/MANUFACTURER
PlasmaCare, Inc., Cincinnati, OH, by fax on January 17, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CA
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0838-09;
b) Plasma Frozen, Recall # B-0839-09
CODE
a) and b) Unit: GS07216
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by fax on December 15, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the drug Avodart, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0841-09
CODE
Units: 9855886, 5758683
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Beaumont, TX, by email on January 5, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0853-09
CODE
Unit: W071208029912
RECALLING FIRM/MANUFACTURER
Medic Inc., Knoxville, TN, by letter dated December 9, 2008. Firm initiated recall is complete.
REASON
Blood product, for which the sample used for nucleic acid testing (NAT) was unsuitable, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0856-09;
b) Recovered Plasma, Recall # B-0857-09
CODE
a) Units: 7298318, 7223170, 5213640, 7186173, 7196347;
b) Units: 7298318 (2 units), 7223170, 7186173, 7196347
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N Goldman Center, Oklahoma City, OK, by facsimile on November 5, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from deferred donors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
IN, CA, NY, AR, OK
___________________________________
PRODUCT
Source Plasma, Recall # B-0858-09
CODE
Units: 365034037, 365032343, 365032013, 365031401, 365031109, 365030591, 365028480, 365028308, 365025572, 365025242, 365023649, 365023213, 365022725, 365013613, 365012487, 365011464, 365010982, 365010373, 365009722, 365009059, 365008769, 365006673, 365006323, 365005670, 365004817, 365000081
RECALLING FIRM/MANUFACTURER
Telecris Plasma Resources, Roanoke, VA, by fax on October 9, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had been incarcerated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
26 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0766-09
CODE
Unit: W040709470042
RECALLING FIRM/MANUFACTURER
Indiana Blood Center, Indianapolis, IN, by telephone on March 20, 2009. Firm initiated recall is complete.
REASON
Blood product, labeled with an incorrect weight, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0804-09
CODE
Units: W127808202579, W127808202298, W127808200964, W127808200106, W127808202703
RECALLING FIRM/MANUFACTURER
Tacoma Pierce County Blood Bank, Tacoma, WA, by letter dated February 27, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was using a non-steroidal anti-inflammatory drug (NSAID) at the time of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
WA
___________________________________
PRODUCT
a) Platelets, Recall # B-0844-09;
b) Red Blood Cells, Recall # B-0845-09
CODE
a) and b) Unit: F49606
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, MI, by fax on December 16, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the medication Bactrim, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland, MI
___________________________________
PRODUCT
Platelets, Recall # B-0851-09
CODE
Unit: W227709380102
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by facsimile on February 13, 2009. Firm initiated recall is complete.
REASON
Blood product collected from a donor with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0863-09
CODE
Unit: 53FN22447
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake and Potomac Region, Baltimore, MD, by telephone and email on May 29, 2007 followed by a letter dated June 13, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________


May 13
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0869-09
CODE
Unit: 9959643
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc. Orlando, FL, by telephone on January 7, 2009. Firm initiated recall is complete.
REASON
Blood product, which was inappropriately distributed in a single storage bag, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0870-09
CODE
Unit: 9937184
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc. Orlando, FL, by telephone on January 14, 2009. Firm initiated recall is complete.
REASON
Blood product, which was inappropriately distributed in two storage bags, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Source Plasma, Recall # B-0867-09
CODE
Unit: 08FMOG6050
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Springfield, MO, by facsimile on March 10, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was not asked the health history questions pertaining to having received growth hormone or gonadotropin, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0894-09
CODE
Units: Y86695, W087608511525
RECALLING FIRM/MANUFACTURER
Virginia Blood Service, Inc. Richmond, VA, by letter dated August 7, 2008 and one dated August 21, 2008. Firm initiated recall is complete.
REASON
Blood products, labeled “leukoreduced”, but which had not undergone leukoreduction, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0899-09;
b) Recovered Plasma, Recall # B-0900-09
CODE
a) and b) Unit: W045007142739
RECALLING FIRM/MANUFACTURER
Community Blood Center of Greater Kansas City, Kansas City, MO, by facsimile and letter dated February 24, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who resided with a person diagnosed with Hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria and KS
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0911-09
CODE
Unit: 6684522 Part 1 and Part 2
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc. Orlando, FL, by telephone on December 14, 2008. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Source Plasma, Recall # B-0691-09
CODE
Unit: JB0099257
RECALLING FIRM/MANUFACTURER
DCI Biologicals Jonesboro, LLC, Jonesboro, AK, by e-mail and telephone on August 11, 2005. Firm initiated recall is complete.
REASON
Blood product, which was untested for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) by the nucleic acid test (NAT) method, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0864-09
CODE
Unit: 35GY34842
RECALLING FIRM/MANUFACTURER
American National Red Cross, Roanoke, VA, by telephone on March 31, 2006. Firm initiated recall is complete.
REASON
Blood product, in which QC for the centrifuge was not performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
__________________________________
PRODUCT
Recovered Plasma, Recall # B-0885-09
CODE
W115908213390
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by electronic mail on February 3 and February 4, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
__________________________________
PRODUCT
Red Blood Cells, Recall # B-0895-09
CODE
Unit: 6914858
RECALLING FIRM/MANUFACTURER
Community Blood Center of the Ozarks, Springfield, MO, by letter dated February 12, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of receiving an allograft, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AK
___________________________________
June 3
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0969-09
CODE
Units: 9098894; 9098598; 9098596
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc. Orlando, FL, by letter on December 12, 2008. Firm initiated recall is complete.
REASON
Blood product, leukodepleted greater than five days after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Fl
PRODUCT
Red Blood Cells Leukocytes Reduced.
Recall # B-0969-09
Units: 9098894; 9098598; 9098596
RECALLING FIRM/MANUFACTURER 
Florida’s Blood Centers, Inc. Orlando, FL, by letter on December 12, 2008. Firm initiated recall is complete.
REASON 
Blood product, leukodepleted greater than five days after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
3 units
DISTRIBUTION
Fl

Being members of the HIV/AIDS and HCV infected hemophilia community has given us a unique view of risk associated with the blood supply and living with the ambiguity of that risk. We, the end users, shoulder the ultimate risk, the potential harm to life and well being when a failure occurs in the management of the blood supply. For ten thousand persons with hemophilia, and roughly twelve to fifteen thousand people who contracted transfusion associated HIV/AIDS, that failure of course did occur, and we were left with the ultimate risk and the ambiguity of living with HIV/AIDS, which at the time was tantamount to a death sentence.

 
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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.