2010-09-05 | Welcome
Posted by Dave Cavenaugh   09-30-2008 WASHINGTON UPDATE
September, 2008 Vol. 10 No. 8

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> STATE-LEVEL ISSUES

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On September 18th, the California Legislature and Governor came together, more than two months after the state’s fiscal year had begun, and agreed to an amount for the 2008-2009 Fiscal Year Budget that all parties were willing to accept. Since over four and a quarter Billion dollars in state expenditures – for health care, education, food and other programs – was held up over this two month period, causing severe hardships on those most in need across the state, pressure was extreme to resolve the matter so checks could flow. The compromise budget creates no new taxes; it does however borrow funds, mostly from future years, to close the current deficit. Savings found also come through increased penalties for corporations late in filing taxes in excess of $1 Million, and in unspecified line-item vetoes by the Governor in months to come.   An estimated $7 Billion additional deficit will be accrued between now and next August 30 when Fiscal Year 2009 ends, so these battles are not over. In terms of specific programs of near-term importance to the hemophilia community, the 10% across-the-board budget cut will be implemented at once in state programs such as the Genetically Handicapped Persons Program (GHPP) which serves many persons with hemophilia.  It will not be implemented in Medi-Cal (Medicaid) payments to pharmacies, due to a court injunction.  Next March 1, the cuts in state-only programs like GHPP will be reduced from 10% to 1%, and cuts in Medi-Cal payments will begin, but only at a 5% level.
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> CONGRESS
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Will the enormous federal expenditures promised this month in financial bailouts force a bare-bones social programs budget next spring? In AIDS programs, HTC funding, and Medicaid? Current thinking seems to be yes, but not entirely – checks for Social Security checks and similar programs will continue to go out.  But a very austere year is shaping up.  Congress, faced with a strong need to adjourn for the year so members can campaign before the upcoming elections, must first decide on a “fix” for the disasters on Wall Street. Its first effort on 9/29 failed by a surprisingly substantial 205 to 228 vote margin.  The nation and the bankers must wait out most of the week until Congress reconvenes to try again.
 
Certain issues remained contentious during negotiations, leading some to emphasize the increasing risk of disaster if action was not taken rapidly. In the end however, these issues (mechanisms for oversight of such a huge program, limitations on executive compensation and mortgage assistance for homeowners) were addressed. Public outcry against the plan, however, built to a higher and higher pitch daily, and contributed to the decisive defeat in the House. Meanwhile, the predicted freezing of credit has begun, permeating the economy and rippling overseas.  One ray of hope is that with the additional time these setbacks have provided, other plans have come forward, for example simple government insurance (vs. via the lenders) of all foreclosed and to-be-foreclosed mortgages.
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Some local and regional businesses have already felt the pinch of not being able to borrow operating moneys from traditional sources, thus having to reduce sales if not close their doors.  Then too, the number of homeowners who have yet to discover that their mortgages have been bought and sold a number of times and become the property of Lehman Brothers or Bear Stearns or Merrill Lynch is very, very large.  This is on top of the Trillions in mortgages owned by Freddie Mac and Fannie Mae.
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The soundness of the solution, and indeed the gravity of the crisis in the first place, are of particular concern to those Americans with high-cost chronic illness who are already going bankrupt at an alarming rate due to their inability to pay outstanding medical bills. Many Americans are facing both chronic illness and foreclosure. Congress has yet to seriously offer help those in financial straits due to health conditions, yet we as part of the larger citizenry are asked to bail out a financial sector that has consistently made short-sighted, mean-spirited decisions.
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Only by the end of the month were any voices raised linking the foreclosure crisis that ostensibly triggered this threat of collapse to the medical costs that in so many cases triggered the foreclosures!  National health care would relieve American companies, large and small, from this escalating cost thereby freeing up serious dollars for economic growth.
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Webster defines “usury” as “the lending of money with an interest charge for its use that is very high or higher than the usual rate.” There is a long history in this country of anti-usury laws. Yet how many of us these days routinely have credit cards with outstanding balances of $10,000 or more, at interest rates of 24% per year if we’ve ever missed one payment? One quarter of the balance per year as the price for borrowing the rest? We have submissively agreed to these terms, but it feels like they are closing in on what Mob loan sharks charge.  This is why we are a nation of debtors (certainly not savers), and our pocketbooks are thus much more vulnerable.  Can we speak up? Is this not the time?  These practices are some of the many exploitative tools used to profit the top 1% of the nation, which earns 20% of the income, at the expense of towns, cities, families, stadium-goers, movie-goers, and all of the rest of us in the “lower 99%.”  Exploiting the American consumer as hard as you can just because you can shows how far we have come from any sense of corporate social responsibility.  “Let the buyer beware” has been the cornerstone of free commerce for a long time, but when practices are abusive, somebody – the indignant press, the suppliers of raw materials to the abusers, and if these are not available the government – must step in.
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Finally, the current Congress has already punted almost the entire year’s US Government operating budget forward into next year. This doubles the fiscal pressure instantly facing that newly configured Congress – to which is then added one more year of an off-budget (costs, but is not responsible for generating any offsetting revenue) multi-billion-dollar-per-year war, and the cost of this bailout, expected to reach $1,000,000,000,000.
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* Freddie Mac was chartered as the Federal Home Loan Mortgage Corporation in 1970.  Fannie Mae was chartered as the Federal National Mortgage Association, originally created in 1938 as a part of the Federal Housing Administration. In 1970 it was ‘spun off’ from the federal government, to join Freddie Mac as “government-sponsored private corporations.”
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> AGENCIES
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FDA
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At the September meeting of the FDA Blood Products Advisory Committee (BPAC), COTT spoke to the issue of allowing donors back in to the donor pool permanently deferred for having repeatedly had inconclusive test results for Hepatitis B core antibodies.  We stressed understanding of the logic behind the proposal (far better tests are available now), and the larger concern to expand the donor pool at any safe opportunity, but felt that current continued proof of organizational mishandling of positive units, whether just donated or in the production process, was reason enough to hold off on such regulatory relaxations.  Our remarks are included at the end of this Update as Attachment #2.
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The possibly deliberate contamination in China earlier this year of much of the supply of heparin used in this country (ostensibly from US firms)  triggered a call on Capitol Hill for more funding for the FDA specifically for in-country inspection of foreign pharmaceutical products destined to be ingredients in drugs used in the US.   While all funding from Congress has been delayed for another six months, barring this from happening, attention here turned back to China as the news showed over 3,000 infants sick and four or more dead from, again, possibly deliberately contaminated infant formula.  Subsequently, concern has been raised that some chocolates made in the west may have used this milk.  The skepticism of Americans concerning Chinese industry and its pharmaceutical arm in particular reached new heights here this month. The Olympics fade fast.
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Our regular feature of excerpts from recent FDA Enforcement Reports can be found at the end of this Update as Attachment #1. Last month we indicated that readers would be able to see in this month’s FDA report information on the recent CSL Behring recall of two lots of factor which tested low potency.  There is apparently a good bit more lag time between recall and a summarized account of it in the Enforcement Reports.  Readers will notice that the dates of the events included in Attachment #1 were for the most part many months ago. And as ever note that the phrase “Firm initiated recall is complete” does NOT mean “None of the product subject to this recall had been used.”
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CDC
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In its mid-year reporting of AIDS statistics, the Centers for Disease Control blatantly tried two tactics to deflect attention from stateside (US) AIDS issues and needs (in favor of the President’s International AIDS program).  Both African-American and Hispanic communities were greatly offended at the precipitous drop in the reported numbers infected (and thus presumably need for funding) in their communities.  We present each below, including community reaction.
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Hispanic AIDS Data
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In the August CDC report on HIV/AIDS, CDC failed to include any data from Puerto Rico, a major part of the US, where HIV/AIDS is a serious problem. Latino AIDS activists exploded over the CDC’s ignoring of the seriousness of HIV/AIDS in Puerto Rico, which has the fifth largest concentration of HIV/AIDS in the United States. Excluding Puerto Rico, they say, lowers the overall estimates for HIV/AIDS in the domestic Latino community. The omission of any data from the Island territory is unfathomable.
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The September 2, 2008 edition of the Kaiser Family Foundation Report, “Health Disparities: A Weekly Look At Race, Ethnicity And Health”, quotes Guillermo Chacon, vice president of the Latino Commission on AIDS: “the share of new HIV infections [in the US] represented by Hispanics increases from the 17.3% reflected in the CDC report to 22% when data on Puerto Rico are included.”
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Accurate new infection estimates also help gauge how quickly HIV is spreading, which groups are at high risk and which areas have higher rates of HIV, all of which are necessary to develop effective prevention and treatment strategies, according to advocates. Chacon said that the report is "not acceptable," adding that the "number the CDC came up with doesn't fully reflect the severity of this epidemic among Latinos." Chacon added that "[n]ew policies" that address HIV/AIDS "are being formulated based, precisely, on the [inaccurate] numbers" in the CDC report.
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For COTT, this is another example of the Bush Administration's lack of any serious domestic response to the HIV/AIDS epidemic. This is not passive omission; an error this grievous is a deliberate downplaying of a critical health need, hardly what the CDC should be known for. It is, however, consistent with an effort to dismantle the public health structure in our nation. Eight years of hostility toward federal regulation of health care and medicine have left a timid, understaffed, and under-funded public health structure, once the world's gold standard. When politicians talk of health care, they rarely, if ever, discuss the status of our public health institutions such as the Public Health Service, The Food & Drug Administration, the Centers for Disease Control & Prevention, or the Health Resources & Services Administration (which supports Ryan White, Community Health Centers, and the Hemophilia Treatment Centers program). These are the cornerstones of our public health system and the damage done by years of neglect and failed changes have left these critical federal agencies in distress in terms of protecting the public health of our nation. (Did you know that some payroll functions at both FDA and CDC are now handled by long-term military armament manufacturer Northrop-Grumman?) It is well beyond the time when this nation needs to re-invest in its public health institutions, most specifically by reducing corporate influence at agencies such as the FDA, and re-invigorating CDC disease tracking and prevention programs and initiatives.
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African-American AIDS Data
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As if dropping a nearby island off of the infection map weren’t enough, it turns out there was an underestimate of HIV/AIDS by the CDC that directly impacted African-Americans. We also learned in August that reporting of HIV cases by CDC had been underestimated by 40 percent. The majority of new HIV/AIDS cases are occurring among African-Americans. While African-Americans make up for 13 percent of this nation’s population they represent 45 percent of the new HIV infections. Marc Morial, the president and CEO of the Urban League stated in an editorial in the Asheville North Carolina Citizen-Times:
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“As the face of AIDS in America has turned increasingly Black, have our federal government and many of our fellow citizens simply stopped paying attention? About 600,000 African Americans are now HIV positive and as many as 30,000 are infected each year. According to an analysis by the Black AIDS Institute, despite extraordinary improvements in HIV treatment, AIDS remains the leading cause of death among Black women aged 25-34, and the second leading cause of death among Black men aged 35-44. Blacks make up 70 percent of new HIV cases among teenagers and 65 percent of HIV-infected newborns. At a time when the actions of our federal government and others are resulting in fewer deaths and greater access to affordable antiretroviral drugs in places like Namibia and Cambodia, more Black Americans are living with AIDS than the infected populations in Botswana, Ethiopia, Guyana, Haiti, Namibia, Rwanda or Vietnam. (emphasis added.) In fact, according to the Black AIDS Institute, if Black America were a country, it would rank 16th in the world in the number of people living with HIV. We must also do more to promote needle exchange programs, improve testing in prisons and deal with issues like poverty, homelessness and drug abuse, which are known incubators for the disease. But government can’t do this job alone. We also must do more in our own communities to change behaviors and end the stigma and homophobia that keep us from reaching out to those in greatest need.”
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As COTT has stated time and time again over the last eight years, it is unconscionable that the Bush Administration has opposed any expansion of the Ryan White Care Act, the nation’s domestic HIV/AIDS program, ignoring the changing face of the epidemic due to the explosion of new cases in communities of color. The disparity in access to care and associated services for the African-American community remains off the charts and is getting worse as inner-city and rural hospitals – already operating on a shoestring -- confront declining funds due to state and federal cutbacks. COTT Board member Larry Allen from the Sickle Cell community stated that “the continued lack of equity in health care access is unconscionable and continues to escalate in the African-American community.” He added that for those in the Sickle Cell community the situation continues to be of serious concern, as on a daily basis families face the same hurdles as other chronic diseases, yet must seek care through the institutional racism still active in American medicine.  
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The dismantling of the public health infrastructure, from federal agencies down to county health departments, that has been insidiously carried out over the last eight years is not only unconscionable but has a huge negative result – the complete lack of any early detection ability for health threats all around us. But no charge we can level is strong enough to censure this administration for these two attacks on public awareness and public support for treatment for the two largest minority populations in the country. COTT President Corey Dubin stated that, “We must fully fund the Ryan White Care Act and return to the government-community model that produced successful prevention interventions in the 1990s, in part because the initiatives were culturally competent and community relevant. To do so is good solid public health policy for the health of our nation.”
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> INDUSTRY 
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CSL
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CSL Behring this month proposed a series of safety seminars for representatives of the hemophilia community.  We are pleased to see this development. CSL has been very helpful in recent years with its support of consultants, travel and lodging in connection with efforts to expand Congressional sponsorship of the MediGap legislation.  The big news about CSL, however, is its purchase of Talecris, a North Carolina based firm with substantial manufacturing and plasma collection operations.  Products include Koate-DVI, a Factor VIII treatment which includes some von Willebrand Factor; Prolastin, the most commonly used Alpha-1 Antitrypsin Deficiency therapy, and a number of immune globulin products. The purchase removes one competitor from CSL’s playing field, and gives it back a supply base it had been lacking for several years. 
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Covidien
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We have an unusual element this month – warning of discovery of a drug’s serious threat specifically to persons with hemophilia.  The drug, Phosphocol, made by Covidien, is used in knee surgery, but fortunately only in conjunction with a type of knee surgery (radiosynovectomy) that is, thanks to earlier disturbing findings of the potential for this effect, no longer common. Here is a report prepared for the Update by Richard Colvin PhD MD, member of the COTT Board and of the FDA’s BPAC:

On 8/29/08, Covidien posted a letter addressed to healthcare professionals on their website warning that the intra-articular injection of the radioactive drug Phosphocol has been linked to the development of leukemia in two boys ages 9 and 14 with hemophilia. Phsophocol contains a radioactive form of phosphorus called P32 and has been used for radiosynevectomies to treat the chronic inflammation that results from multiple bleeds in target joints in persons with hemophilia. Although Phosphocol was never approved for use in radiosynovectomies, it has been used “off-label” for this indication. During the past 10 years the number of radiosynovectomies performed for joint disease has gone down with the recognition of a possible link between the use of radioactive material in the joint space and the future development of leukemia.

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At this time, we recommend that radiosynovectomy for hemophilia-associated synovitis be discontinued until a better understanding of the link between radiosynovectomy and leukemia development is established. Our further concern is that given the method of distribution of the letter from Covidien, many physicians who treat people with hemophilia will not be made aware of the potential link between radiosynovectomy and leukemia. For this reason, we recommend that Covidien directly contact all of the Hemophilia Treatment Centers and recommend that the “off-label” use of Phosphocor for radiosynovectomy be discontinued.

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Summary:

  1. Phosphocol is a drug that contains the radioactive compound P32.
  2. Phosphocol is approved to treat metastatic cancer.
  3. Phosphocol has been used in “off-label” radiosynovectomies to treat joint disease in persons with hemophilia.
  4. Phosphocol has been linked to the development of leukemia in two children with hemophilia.
  5. Previously, radiosynovectomies have been linked to the development of leukemia in children with hemophilia.
Recommendations:
  1. Discontinue radiosynovectomies at this time.
  2. Continue to investigate the link between radiosynovectomies and leukemia.
  3. Covidien directly contact all Hemophilia Treatment Centers and ask that Phosphocol no longer be used for radiosynovectomies.
> COALITIONS
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Efforts are still needed to expand support and endorsement for the Lifetime Caps legislation currently under consideration in both House and Senate by a broader coalition of the disability and other groups its passage would benefit. We often say hemophilia is one of the two or three highest cost medications for chronic illness in the country, but with newer drugs and rising overall health care costs there are many in other communities facing shorter term (but still several years) challenges over the exorbitantly high costs of the medications they require.
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BLOOD SAFETY SUMMARY
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At the September BPAC meeting an FDA proposal to allow back into the donor pool those who had repeatedly had inconclusive tests for Hepatitis B core antibodies was presented. COTT spoke against the proposal, indicating that testing may have improved but materials handling seems not to have if the ongoing Consent Decree with multi-million dollar fines each year against American Red Cross is any indication.  Selections from current FDA Enforcement Reports are included in this Update as Attachment #1.



COTT acknowledges the assistance of Hemophilia Health Services and Factor Support Network

in publication of this issue of the COTT Washington Update.

Committee of Ten Thousand  236 Massachusetts Ave., NE Suite 609 Washington, DC  20002
800-488-2688 * 202-543-6720 fax
cott-dc@earthlink.net * WWW.COTT1.ORG


Attachment #1: Recent FDA Enforcement Report excerpts

September 3
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1820-08
CODE
Unit: 72C075075
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on August 28, 2007. Firm initiated recall is complete.
REASON
Blood component, processed from Whole Blood more than 8 hours after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
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PRODUCT
Red Blood Cells, Recall # B-1823-08
CODE
Units: 72E345330; 72E345471; 72E345286
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on December 20, 2007. Firm initiated recall is complete.
REASON
Blood products, in transit for more than 48 hours and possibly exposed to unacceptable shipping temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
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PRODUCT
Source Plasma, Recall # B-1944-08
CODE
Unit: TQ005791
RECALLING FIRM/MANUFACTURER
IBBI dba Knoxville Plasma, Corp., Knoxville, TN, by fax on April 17, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose scheduled physical exam was overdue, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
September 10
PRODUCT
Corneas, Human Tissue, Recall # B-1653-08
CODE
07080457 OD, 07080457 OS
RECALLING FIRM/MANUFACTURER
Recalling Firm: Old Dominion Eye Foundation, Inc., Richmond, VA, by letter on April 7, 2008.
Manufacturer: Washington Regional Transplant Consortium, Annandale, VA. Firm initiated recall is complete.
REASON
Donor history indicated increased risk factors for Creutzfeldt-Jacob disease but the donor was deemed eligible to donate. Tissues had been distributed for transplantation.
VOLUME OF PRODUCT IN COMMERCE
2 corneas
DISTRIBUTION
Lima, Peru
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PRODUCT
a) Recovered Plasma, Recall # B-1794-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-1795-08
CODE
a) and b) Unit: 206634400
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lafayette, LA, by telephone, letter, or electronic mail on September 26, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who subsequently reported a previously reactive test for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA, Switzerland
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PRODUCT
Red Blood cells, deglycerolized, leukocytes reduced, Recall # B-1875-08
CODE
Unit: 2030991
RECALLING FIRM/MANUFACTURER
Indiana Blood Center, Indianapolis, IN, by telephone on January 8, 2008 and by letter dated January 18, 2008. Firm initiated recall is complete.
REASON
Blood product, which had been deglycerolized did not undergo quality control testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
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PRODUCT
Fresh Frozen Plasma, Recall # B-1877-08
CODE
Unit: 160291195
RECALLING FIRM/MANUFACTURER
Blood Systems Inc/dba United Blood Services, Meridian, MS, by telephone on December 28, 2007. 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
AL
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PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B1878-08
CODE
Unit: 026FZ11770
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by telephone and letter on May 12, 2007.
Manufacturer: The American National Red Cross, Mobile, AL. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had previously tested reactive for Hepatitis C antibody (anti-HCV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
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PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-1900-08
CODE
Unit: 1408541
RECALLING FIRM/MANUFACTURER
Recalling Firm: Indiana Blood Center, Indianapolis, IN, by telephone on March 5, 2008 and by letter dated March 12, 2008.
Manufacturer: Indiana Blood Center, Muncie, IN. Firm initiated recall is complete.
REASON
Blood product, found to be contaminated with Corynebacterium species using the BacT ALERT System, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
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PRODUCT
Red Blood Cells (Apheresis), Recall # B-1998-08
CODE
Unit: 1405724
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by telephone on November 26, 2007 and by letter on December 20, 2007. Firm initiated recall is complete.
REASON
Blood product, for which Quality Control was not performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 component
DISTRIBUTION
OH
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PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-1986-08
CODE
Units: 165503392 (Split unit)
RECALLING FIRM/MANUFACTURER
Blood Systems Inc/dba United Blood Services, Meridian, MS, by telephone on April 08, 2008. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Diptheroid bacilli, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MS


September 17
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1662-08
CODE
Units: 9892315 (Split Unit)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on January 17, 2007. Firm initiated recall is complete.
REASON
Blood products, with positive bacterial detection testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
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PRODUCT
Source Plasma, Recall # B-1758-08
CODE
Unit: KZ009071
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Memphis, TN, by facsimile on February 15, 2006 and by letter on February 20, 2006. Firm initiated recall is complete.
REASON
Blood product, which tested repeatedly reactive for the antibody to hepatitis C virus (anti-HCV), but was labeled as testing negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma, Recall # B-1931-08
CODE
Units: I50030205, I50030026, I50029722, I50029554, I50029254, I50029089, I50028727, I50028547, I50028086, I50027821, I50027575, I50027364, I50027080, I50026824, I50026477, I50026357, I50026050, I50025387, I50025017, I50024651, I50024498, I50024057, I50023950, I50023567, I50023399, I50023132, I50023001, I50022533, I50022502, I50021976, I50025548
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Tuscaloosa, AL, by fax on April 8, 2005. 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
31 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1937-08
CODE
Unit: 4987935
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Monroe, LA, by telephone and fax on June 18, 2008. Firm initiated recall is complete.
REASON
Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1956-08
CODE
Unit: 2809914
RECALLING FIRM/MANUFACTURER
Indiana Blood Center, Indianapolis, IN, by telephone on April 28, 2008 and follow-up letter dated June 19, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported living in a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
___________________________________
PRODUCT
a) Recovered Plasma, Recall # B-1927-08
b) Red Blood Cells Leukocytes Reduced, Recall # B-1928-08
CODE
a) and b) Unit: W25024
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Traverse City, MI, by email or fax on June 24, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a bone graft within one year of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI, Switzerland
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September 24
PRODUCT
a) Red Blood Cells, Recall # B-1753-08;
b) Recovered Plasma, Recall # B-1754-08
CODE
a) and b) Unit: 1470673
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter dated September 8, 2006 and electronically on September 7, 206. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL, Switzerland
___________________________________
PRODUCT
Source Plasma, Recall # B-2002-08
CODE
Units: 382058444, 382058463, 382063380, 382065949, 382066116, 382067041, 382074388, 382078691, 382079617, 382079953, 382087042, 382087717
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Tuscaloosa, AL, by fax on May 7, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously permanently deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-2019-08
CODE
Unit: 9426027
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSource, Glenview, IL, by telephone on June 18, 2008.
Manufacturer: LifeSource Portage Park, Chicago, IL. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose wife completed the donor history form, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
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Red Blood Cells Leukocytes Reduced, Recall # B-1820-08Unit: 72C075075LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on August 28, 2007. Firm initiated recall is complete.Blood component, processed from Whole Blood more than 8 hours after collection, was distributed.1 unitAL ___________________________________Red Blood Cells, Recall # B-1823-08Units: 72E345330; 72E345471; 72E345286LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on December 20, 2007. Firm initiated recall is complete.Blood products, in transit for more than 48 hours and possibly exposed to unacceptable shipping temperatures, were distributed.3 unitsFL___________________________________Source Plasma, Recall # B-1944-08Unit: TQ005791IBBI dba Knoxville Plasma, Corp., Knoxville, TN, by fax on April 17, 2007. Firm initiated recall is complete.Blood product, collected from a donor whose scheduled physical exam was overdue, was distributed.1 unitNCCorneas, Human Tissue, Recall # B-1653-0807080457 OD, 07080457 OSRecalling Firm: Old Dominion Eye Foundation, Inc., Richmond, VA, by letter on April 7, 2008. Manufacturer: Washington Regional Transplant Consortium, Annandale, VA. Firm initiated recall is complete.Donor history indicated increased risk factors for Creutzfeldt-Jacob disease but the donor was deemed eligible to donate. Tissues had been distributed for transplantation.2 corneasLima, Peru ___________________________________a) Recovered Plasma, Recall # B-1794-08;b) Red Blood Cells Leukocytes Reduced, Recall # B-1795-08a) and b) Unit: 206634400Blood Systems, Inc., Lafayette, LA, by telephone, letter, or electronic mail on September 26, 2007. Firm initiated recall is complete.Blood products, collected from a donor who subsequently reported a previously reactive test for hepatitis, were distributed.2 unitsLA, Switzerland___________________________________Red Blood cells, deglycerolized, leukocytes reduced, Recall # B-1875-08Unit: 2030991Indiana Blood Center, Indianapolis, IN, by telephone on January 8, 2008 and by letter dated January 18, 2008. Firm initiated recall is complete.Blood product, which had been deglycerolized did not undergo quality control testing, was distributed.1 unitIN___________________________________Fresh Frozen Plasma, Recall # B-1877-08Unit: 160291195Blood Systems Inc/dba United Blood Services, Meridian, MS, by telephone on December 28, 2007. Firm initiated recall is complete.Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.1 unitAL ___________________________________Red Blood Cells Leukocytes Reduced, Recall # B1878-08Unit: 026FZ11770Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by telephone and letter on May 12, 2007. Manufacturer: The American National Red Cross, Mobile, AL. Firm initiated recall is complete.Blood product, collected from a donor who had previously tested reactive for Hepatitis C antibody (anti-HCV), was distributed.1 unitFL___________________________________Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-1900-08Unit: 1408541Recalling Firm: Indiana Blood Center, Indianapolis, IN, by telephone on March 5, 2008 and by letter dated March 12, 2008. Manufacturer: Indiana Blood Center, Muncie, IN. Firm initiated recall is complete.Blood product, found to be contaminated with Corynebacterium species using the BacT ALERT System, was distributed.1 unitIN___________________________________Red Blood Cells (Apheresis), Recall # B-1998-08Unit: 1405724LifeShare Community Blood Services, Elyria, OH, by telephone on November 26, 2007 and by letter on December 20, 2007. Firm initiated recall is complete.Blood product, for which Quality Control was not performed, was distributed.1 componentOH___________________________________Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-1986-08Units: 165503392 (Split unit)Blood Systems Inc/dba United Blood Services, Meridian, MS, by telephone on April 08, 2008. Firm initiated recall is complete.Blood products, which were possibly contaminated with Diptheroid bacilli, were distributed.2 unitsMSPlatelets Pheresis Leukocytes Reduced, Recall # B-1662-08Units: 9892315 (Split Unit)Florida’s Blood Centers, Inc., Orlando, FL, by telephone on January 17, 2007. Firm initiated recall is complete.Blood products, with positive bacterial detection testing, were distributed.2 unitsFL___________________________________Source Plasma, Recall # B-1758-08Unit: KZ009071Plasma Biological Services, Inc., Memphis, TN, by facsimile on February 15, 2006 and by letter on February 20, 2006. Firm initiated recall is complete.Blood product, which tested repeatedly reactive for the antibody to hepatitis C virus (anti-HCV), but was labeled as testing negative, was distributed.1 unitNC___________________________________Source Plasma, Recall # B-1931-08Units: I50030205, I50030026, I50029722, I50029554, I50029254, I50029089, I50028727, I50028547, I50028086, I50027821, I50027575, I50027364, I50027080, I50026824, I50026477, I50026357, I50026050, I50025387, I50025017, I50024651, I50024498, I50024057, I50023950, I50023567, I50023399, I50023132, I50023001, I50022533, I50022502, I50021976, I50025548Talecris Plasma Resources, Inc., Tuscaloosa, AL, by fax on April 8, 2005. Firm initiated recall is complete.Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.31 unitsNC___________________________________Platelets Pheresis Leukocytes Reduced, Recall # B-1937-08Unit: 4987935LifeShare Blood Centers, Monroe, LA, by telephone and fax on June 18, 2008. Firm initiated recall is complete.Blood product, labeled with an extended expiration date, was distributed.1 unitLARed Blood Cells Leukocytes Reduced, Recall # B-1956-08Unit: 2809914Indiana Blood Center, Indianapolis, IN, by telephone on April 28, 2008 and follow-up letter dated June 19, 2008. Firm initiated recall is complete.Blood product, collected from a donor who reported in a malarial endemic area, was distributed.1 unitIN___________________________________a) Recovered Plasma, Recall # B-1927-08b) Red Blood Cells Leukocytes Reduced, Recall # B-1928-08a) and b) Unit: W25024Michigan Community Blood Center, Traverse City, MI, by email or fax on June 24, 2008. Firm initiated recall is complete.Blood products, collected from a donor who received a bone graft within one year of donation, were distributed.2 unitsMI, Switzerland___________________________________a) Red Blood Cells, Recall # B-1753-08;b) Recovered Plasma, Recall # B-1754-08a) and b) Unit: 1470673 Memorial Blood Centers, Saint Paul, MN, by letter dated September 8, 2006 and electronically on September 7, 206. Firm initiated recall is complete.Blood products, collected from a donor with a history of jaundice, were distributed.2 units IL, Switzerland___________________________________Source Plasma, Recall # B-2002-08Units: 382058444, 382058463, 382063380, 382065949, 382066116, 382067041, 382074388, 382078691, 382079617, 382079953, 382087042, 382087717Talecris Plasma Resources, Inc., Tuscaloosa, AL, by fax on May 7, 2008. Firm initiated recall is complete.Blood products, collected from a donor who was previously permanently deferred, were distributed.12 unitsNC___________________________________Fresh Frozen Plasma, Recall # B-2019-08Unit: 9426027Recalling Firm: LifeSource, Glenview, IL, by telephone on June 18, 2008. Manufacturer: LifeSource Portage Park, Chicago, IL. Firm initiated recall is complete.Blood product, collected from a donor whose wife completed the donor history form, was distributed.1 unitIL___________________________________

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Attachment #2: COTT Testimony at 9/08 BPAC
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Committee of Ten Thousand
Advocates for Persons with HCV-HIV/AIDS
236 Massachusetts Ave., NE Suite 609 · Washington, DC  20002
(202) 543-0988 · (202) 543-6720 fax  · www.cott1.org · cott-dc@earthlink.net
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TESTIMONY before the
FDA Blood Products Advisory Committee
September 11, 2008 – Rockville, MD
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Donor Re-Entry When Repeatedly Reactive HBV Core Antigen Tests
are Followed by Negative Nucleic Acid Tests
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The Committee of Ten Thousand (COTT) is pleased to be able to address the committee on this important new proposal to relax current lifetime deferral criteria.
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The basis for the proposed change and the re-entry of these previously deferred donors is the issue of false positives in HBV Core Antigen testing. With the more sensitive NAT (Nucleic Acid Test) testing now widely in use, donors who were deferred for repeatedly reactive HBV Core Antigen tests may be eligible for re-entry as donors: past less-sensitive HBV Core Antigen testing had false positive rates much higher than today. COTT supports the concept of donor re-entry, where safe -- NAT testing showing an earlier reactive HBV Core Antigen test was a false positive may suffice; we would view it as necessary although perhaps not sufficient.
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A positive result on a Core Antigen test or a Surface Antibody test usually identifies a person who has cleared the virus … but not always.  If a person has had the virus, he/she will have antibodies produced; the antibodies clear some time after the virus clears.  A positive Core Antigen test result is harder to interpret.  For one thing, it may clear in time, or it may not. In the absence of a positive Surface Antigen test, moreover, it may be caused by pathologies unrelated to hepatitis, such as auto-immune conditions. 
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In the early days of AIDS, or GRID, Hepatitis C had not been identified, nor had HIV.  However the disease sweeping one community, and appearing with alarming frequency in ours, bore enough similarities to a hepatitis that clinicians were beginning to use Hepatitis B Core Antigen tests as a surrogate for one or both of these conditions – clearly they were both blood-transmissible.  It would not be too long before clinicians and regulators alike realized that this blood transmission was coming from the blood supply itself – threatening the entire nation.
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However, clinician astuteness was not followed up by agency alertness.  Hepatitis B Core Antigen testing as a surrogate marker for HCV and/or HIV was never mandated.  The Committee members are well aware of how many lives were lost in our community subsequently.
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We developed a healthy (sic) respect for the certainty that a positive HBV Core Antigen test conveyed, in light of the marker value it had at the time.  Therefore there is still an extent to which we have a visceral reaction on hearing a person tests positive for it. 
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A positive HBV Core Antigen test in the past, when used as a surrogate marker, was widely known as the “behavior” test – suggestive of a donation at risk for these or other blood-borne pathogens. At the time, when Non-A Non-B and HIV were proliferating though tests were not available, the tendency was to take any suggestion of blood-borne contagious pathogens as a basis for excluding donors.
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Today that is far less of a concern as other tests have been developed, and especially since the onset of widespread PCR testing.  However, our earlier point remains, that a positive (or indeterminate) Core Antigen test may be triggered by other factors.  If we no longer rely on this test, which means its use will be discontinued, we will lose that small indication of other risks.
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We encourage the committee to consider a 6 to 12 month delay in acting on this proposal while further study offers clarification on the risk of loss of informative data should the HBV Core Antigen test be discontinued.
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Units testing positive or negative for key viruses are then placed in appropriate channels. We remind FDA/CBER and the blood industry that humans run the computers, and humans move the supplies around, so humans will still make errors.   The ongoing inability of the American Red Cross to fix its operating procedures, correctly screen donors and get its overall blood operations in order, even after tens of millions of dollars in fines, proves our point. COTT continues to counsel caution when changes in donor screening and eligibility are proposed.
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We are mindful of the need to expand the nation’s donor pool. However, without the political will necessary to connect blood donation to good citizenship, the situation will remain difficult and the donor pool will not grow significantly enough to meet projected demand. The blood industry and our political leadership should teach our children in the schools the importance of regular blood donations. In this election year we need to put regular blood donations on the political table. If former Presidents Bush and Clinton can raise awareness about Hurricane Katrina in television spots, then it is also possible for our leaders to regularly and repeatedly encourage donation.
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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.

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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.

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