| Posted by
Dave Cavenaugh 04-21-2008 |
WASHINGTON UPDATE |
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March-April 2008 Vol. 10 No. 3
> Congress
Recoiling from the Proposed Fiscal Year 2009 Budget sent to the Hill by the President in late February, yet burned by the memory from last December of his rigid refusal to sign any funding bill that went over his targets, the two chambers began their annual process to develop their own Budget documents in March, necessary before Appropriations bills can be developed. Ideological lines do not seem to be drawn in the same way as last year, when the two sides of the Hill could not agree on a single Budget (and therefore were less equipped to resist efforts to exceed targets). Instead this year’s Economic Stimulus Package of several hundred billion, the enormity of the expenditures for US actions in Iraq and Afghanistan, and the rising profile of the Presidential election have had their attention. Oh and of course major league baseball drug use.
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Telephone surveillance oversight, renewal of the administration program for helping to fund global AIDS efforts, and follow-up oversight of the housing crisis have also been targeted. The Bear Stearns brokerage failure in mid-March was headed off at the 11th hour by the US Government over fears that if it fell, other houses could fall, in a ‘domino effect’ that could hurt the economy far more severely than the housing crisis has. The event underscored the seriousness of the ripple effects throughout the economy of what began as a housing crisis alone. The Wall Street action happened just as Congress adjourned for two weeks, although on their return they quickly summoned the senior officials involved to brief members.
The first legislation to address the economic crisis, passed by the Senate April 10, was repudiated by many. It gave only minor relief to the actual victims of the crisis, homeowners who succumbed to strong sales pitches from realtors and financiers pushing them into higher cost homes than the applicant’s records clearly showed they could meet payments on. The bill provided other assistance, to home-builders for example, but was held as wanting on all fronts, and was not improved before being signed into law.
In state news, COTT has helped in the fight to reverse recently enacted cuts in California state health and other programs. We have given testimony before the State Legislature's Health Committee in Sacramento, and met with several key Budget Committee offices. In addition, through the courtesy of the Comcast cable network there, we recorded a short video on the issues, to be aired in a local segment on CNN Headline News in central California repeatedly over the next month. More advocacy work will be needed to achieve success at giving the Legislature the commitment to undo their rushed consent in February to the Governor's proposed ten percent across the board cuts. Any such cuts must be targeted in a way that exempts life-or-death services to health communities like ours.
Key California legislators tell us that for the most part members of both the Governor's Republican party and the Legislature’s Majority party, Democrats, are by now well aware of the dire implications of the cuts, but need to see evidence from their home district constituencies of this awareness before they can take stands needed, which otherwise might be unpopular, in order to undo cuts already approved and block further cuts. Californians are urged to mobilize their resources for visible, local statements (op-ed, etc.) and events (rallies or speeches at other events, with advance notice to media). COTT is working closely with the Hemophilia Council of California (510-234-8655) on this campaign; contact either HCC or COTT for more information. COTT will speak to community members on this at the upcoming Advocacy Day being held by the Hemophilia Association of SoCal (888-371-4123) in Los Angeles.
The California Medicaid program (known there as Medi-Cal) serves one-fifth of all Medicaid clients in the country. Other states' Medicaid programs are also in fiscal crisis. If California’s cuts are the deepest, that will quickly become the norm across the land.
Also in California, State Sen. Darrell Steinberg (D-Sacramento) in early April introduced a Hemophilia Standards of Service bill (SB 1594), through the Senate Health Committee. The bill, drafted by the Hemophilia Council of California, differs somewhat from the New Jersey Standards of Care legislation, but addresses many of the same concerns. Steinberg becomes President Pro Tem of the Senate starting in the fall, which should help the bill’s chances.
> Agencies
In the last Update we showed via FDA Enforcement Report excerpts why vigilance is still vitally needed, augmenting the inter-hemophilia-organization joint letter to producers and regulators alike. This month we also follow up on some work you read about here last fall: collection of plasma from Mexican citizens into US-labeled shipments. At the time, the background knowledge of the gradual spread of Dengue northward through Central America and to the US border was cited; the response was that Dengue was an envelope virus that would be killed in the fractionation process, and anyway it was not found in this donor population.
But donors of whole blood may present a higher risk to the blood supply. The spread of Dengue is increasing, has crossed the US border, is carried by a type of mosquito that has become endemic to the US only recently (and which can convey up to 30 viruses) – and because it is not currently being tested for as part of the donor screen anywhere in the US, including Texas. A test has been developed abroad and is in limited use; petitioning for FDA certification is possible. For the time being, donors of whole blood are screened for Dengue, as they are verbally screened for malaria by asking what countries they have visited: globally, areas endemic to malaria and Dengue overlap. As the Director of Institute on Infectious diseases at NIH noted in a recent article on the spread of Dengue into the US, “the sometimes deadly disease is again striking US individuals, causing an epidemic in Hawaii in 2001, [and] appearing with unprecedented severity along the Texas-Mexico border.” (Dengue and Hemorrhagic Fever, Fauci & Morens, JAMA 1/9-16/2008) (emphasis added).
Bad Blood at the Front
Another blood safety story made the news in April. British authorities admitted that 18 British soldiers injured in the Middle East and six civilians received blood donated through the US Department of Defense that had not been tested for HIV or HCV. The field hospitals where they were treated, which resemble MASH units, are erected near combat areas. The British Defense Minister said the patients would have died if they had not received the blood, but is offering free testing and counseling. The US Department of Defense said it does not have the resources or time to properly screen blood donors during combat situations. The CEO of Britain’s Haemophilia Society said it was extremely worrying that these patients had been exposed to an unacceptable risk.
Continuing in our efforts to demonstrate that vigilance will easily show that problems in blood products exist, you will find in Attachment 1 to this Update excerpts from April FDA Enforcement Reports.
Heparin
Yet another safety story, though more of a drug issue than a blood issue specifically, is the issue of Heparin. The blood thinner is widely used in the hemophilia community as a line cleaner after infusion by port. It is far more widely used in general in medicine and surgery for similar applications. Based on a great increase in adverse effect reports in December, Baxter on January 17 began a recall of nine lots of heparin. Adverse effects reports, however, continued at high levels. Accordingly, on February 11th, the FDA issues and Alert advising healthcare practitioners to switch suppliers and limit use of Heparin in general until further notice. The agency noted that an annual rate of fewer than 100 reported adverse effects in all of last year had skyrocketed to some 350 in just the first six weeks of this year (equal to an annual rate of over 3000). On February 12th Baxter announced a temporary suspension of production of heparin in the vial size that makes up 75% of Baxter’s heparin production. Baxter did not, however, implement a recall of product already manufactured, citing (with FDA concurrence) its wide use and thus the need to avoid shortages. Baxter produces about half of the heparin sold in the US. FDA is looking at other makers for adverse effect reports.
The adverse effects have all been reported from high-dose “bolus” injection (vs more gradual infusion) uses only, not small doses used to flush ports and catheters. As a result, there has been little exposure in hemophilia. However, one of the uses of bolus heparin at least relevant to the hemophilia world is as an emergency measure in a plasma collection center, FDA says.
FDA’s investigation of the problems found that Baxter contracted heparin production to a Wisconsin company which in turn subcontracted the work to a Chinese concern. FDA had attempted to inspect the Chinese firm but did not do so due to a misidentification of the facility in its records. This case provides strong and recent emphasis on the danger inherent in the FDA’s limited ability to prove the safety and effectiveness of drugs manufactured abroad for US concerns, and for US consumption. The Government Accounting Office found in a November 2007 report that while FDA inspects US drug plants every two years as required, its rate drops to once every 13 years for plants abroad. The news of the danger was communicated inconsistently in the hemophilia community. The standard FDA method of communicating recalls and safety notices is to providers only, not directly to patients. COTT has learned of home care companies which have received the FDA Alert, but not instructed their field staff to urge clients to use alternatives. Sometimes this has been deliberate, as with internal communications that acknowledge receipt of the Alert, but announce to staff a decision that the danger was too remote to change prescriptions. In other cases, it has been by inaction, reasons unclear. There has as a result been substantial concern, and unwarranted shouldering of risk, known or unknown, throughout the community.
COTT urges families with concerns on this matter, who have not heard from their healthcare provider about switching away from Baxter heparin temporarily, to contact their state organizations, so that it can be determined if another combined communication to regulators is necessary.
Pig Brains
This may be as good a place as any for a few notes about a recently-recognized condition among slaughterhouse workers. The video of mishandling cattle that triggered a major beef recall a few months back gives only a little idea of the standard procedures used in such work. Early in the course of learning about Mad Cow and CJD one learns what goes on in the “next room” – where cattle we saw in the yard in that video are taken inside, killed and slaughtered. Procedures have changed due to Mad Cow, but are still pretty gruesome, and forceful, as you might expect. Regarding the pig story: Mad Cow has shown up in many species, but not particularly in pigs. The illnesses documented in recent articles related more to the procedure that was in use, not the condition of the animals. Since pig brains are a delicacy in some countries, three pig slaughterhouses in the US alone produce them – by blowing the brains out of the pigs’ heads with compressed air. Only workers performing this procedure became ill. It is theorized that the force of the compressed air vaporized some of the brain material, which was then inhaled, triggering an immune system response. The condition is not fatal, and not contagious. It is not known how many processing plants abroad perform this procedure. Apparently, the resulting product is free enough from such vapors as to not be capable of triggering an immune response, but that’s another research project.
> Industry
On March 12, the value of Wellpoint's common stock dropped 28% in one day. Since the first of the year, the total drop has been 50 percent -- by some measures half the worth of the company! This means desperation within the company to eliminate what it announced to be the single greatest factor for the stock drop: high medical costs. As more states’ Blue Cross programs require hemophilia members to use only nextRx, it seems targeting our population in the ways they have will only raise their costs.
COTT continues to monitor the Wellpoint/Anthem specialty pharmacy, Precision Rx and the implementation of their hemophilia program. We continue to hear stories about the difficulties people are experiencing with the implementation. The Wellpoint situation is not occurring in a vacuum and is representative of larger issues related to third-party payers and how they view chronic diseases such as hemophilia and other bleeding disorders.
COTT believes that what is lacking from the larger debate is the goal of positive health outcomes for the end users of health care. This is especially relevant for those confronting chronic diseases. We view the current “cost containment” mantra as mindless and contrary to the health and wellness of those with chronic illness. Cost containment without a clear commitment to positive health outcomes can only lead to higher costs in the future for those with chronic disease. Issues of disease management and medication compliance get lost in the narrow cost containment discussion which currently surrounds us.
> Coalitions
In its work concerning the California budget cuts, COTT, especially through its California-based affiliate COTT/West, has been working closely with the Hemophilia Council of California, as mentioned above, as well as with regional organizations around the state to coordinate events and other activities targeted at key legislators in their home district.
This cooperation can now extend nationwide, with the news that Val Bias, who has been serving as the Director of the Hemophilia Council of California, is to shortly become the Chief Executive Officer of NHF! We congratulate Val and look forward to continuing a sixteen-year history of working with him on behalf of the hemophilia community.
> COTT Operations
COTT has been working to support state organizations challenging Wellpoint’s plan to force them under one pharmacy, and working California more intensively due to both this and the state’s fiscal crisis, with several trips during March, COTT is planning its next Town Meeting, and two other presentations in the days prior to that: at the Advocacy Day of the Southern California chapter, and two days later, as part of a press conference led by Santa Barbara, CA City Council members on the state budget crisis. The Town Meeting, four days after that, will be at 6:30 pm on May 2 at the HFA Symposium in Little Rock, AR.
BLOOD SAFETY SUMMARY
Dengue is a concern in whole blood collection along the US-Mexican border. The range covered by the disease has moved into the US there, with every expectation of greater expansion in the country. Although it is a type of virus that the manufacture of plasma-derived clotting factor can eliminate, there is no current screen for Dengue in whole blood collection, other than exclusions to malaria-endemic areas, which historically have approximated Dengue-endemic areas.
British soldiers in the Middle East were given blood untested for HIV and HCV at a combat field hospital. They likely would have died without it. The US Department of Defense, which collected the blood, said it did not have time or resources to properly screen blood donors in such situations. The Haemophilia Society in the U.K. called the incident unacceptable.
The FDA Enforcement reports continue to show units being collected in substandard ways. For all that are intercepted, we are concerned that many more get out and are used. Tracing adverse outcomes back to a given exposure is not always easy, sometimes impossible.
COTT acknowledges the assistance of Hemophilia Health Services and Factor Support Network in publication of this issue of the COTT Washington Update.
Attachment #1 – Recent FDA Enforcement Report Excerpts
April 9
PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1051-08;
b) Fresh Frozen Plasma, Recall # B-1052-08
CODE
a) Unit: 123795411;
b) Units: 123795411 Split 1, 123795411 Split 2
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ, by facsimile on December 31, 2007 and letter on January 8, 2008.
Manufacturer: Blood Systems, Inc., Albuquerque, NM. Firm initiated recall is complete.
REASON
Blood products, which tested negative for HIV, but was collected from a donor who previously tested positive for HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NM
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PRODUCT
Recovered Plasma, Recall # B-1055-08
CODE
Unit # LE77385
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, consignee by electronic mail on November 17, 2005. 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
Switzerland
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PRODUCT
a) Platelets Pheresis Leukocytes Reduced, Recall # B-1069-08;
b) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-1070-08
CODE
a) Units: 49GP24201 (2 units), 49GP20688 (2 units), 49GP24612 (2 units),
49GP23239 (2 units), 49GP22095, 49GP23844, 49GP21536, 49GP22735 (2 units),
49GP24850 (2 units), 49GP23293, 49GP23091, 49GP21559 (2 units), 49GP23183 (2
units), 49GP24619 (2 units), 49GP23146 (2 units), 49GP22681 (2 units), 49GP17400
(2 units), 49GP23242, 49GP23243 (2 units), 49GP23588 (2 units), 49GP24141,
49GP23809, 49GP23238 (2 units), 49GP24446 (2 units), 49GP24477 (2 units);
b) Units: 49GP25337, 49GP22095, 49GP18659 (2 units), 49GP24141
RECALLING FIRM/MANUFACTURER
American National Red Cross SW Region – HT, Tulsa, OK, by telephone beginning July 14, 2005 and follow-up letters dated October 10, 2005. Firm initiated recall is complete.
REASON
Blood products, collected using apheresis kits that had exceeded the acceptable time periods for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
47 units
DISTRIBUTION
TX, OK
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PRODUCT
Source Plasma, Recall # B-1084-08
CODE
Units: 05EWIE4335, 05EWIE5036, 05EWIE5864
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP, Deerfield IL, by fax on October 3, 2005.
Manufacturer: BioLife Plasma Services, L.P., Eau Claire, WI. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Vienna, Austria
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PRODUCT
Platelets Irradiated, Recall # B-1099-08
CODE
Unit: E31022
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Saint Joseph, MI, by facsimile on October 20, 2007. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1120-08;
b) Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated, Recall # B-1121-08
CODE
a) and b) Unit: 247491117
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ, by telephone on December 22, 2004.
Manufacturer: Blood Systems Inc., Rapid City, SD. Firm initiated recall is complete.
REASON
Blood products, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MS, SD
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PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1075-08
CODE
Unit: 314079473
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on April 27, 2007.
Manufacturer: Blood Systems Inc/dba United Blood Services, Tupelo, MS. Firm initiated recall is complete.
REASON
Blood product, which may have been shipped under unacceptable temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS
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PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1076-08
CODE
Unit: 200400758
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on June 15, 2007.
Manufacturer: Blood Systems Inc., Lafayette, LA. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
April 16
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PRODUCT
Source Plasma, Recall # B-1092-08
CODE
Units: 05GWIG7642, 05GWIG8334, 05GWIG9440, 05GWIH0121, 05GWIH1171, 05GWIH1847, 05GWIH2969, 05GWIH3675, 05GWIH4747 ,05GWIH5363, 05GWIH6431
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP, Deerfield, IL, by facsimile on January 17, 2006.
Manufacturer: BioLife Plasma Services, LP, Green Bay, WI. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom post donation information was provided regarding multiple high-risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1106-08
CODE
Unit: 4766018
RECALLING FIRM/MANUFACTURER
Indian Blood Center, Indianapolis, IN, by telephone on November 30, 2007 and by letter dated December 19, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected in a manner that may have compromised the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
___________________________________
PRODUCT
Red Blood Cells Irradiated, Recall # B-0392-08
CODE
Unit: 0408195
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on April 5, 2007 and by letter dated April 11, 2007. Firm initiated recall is complete.
REASON
Blood product, documented as being out of controlled storage for more than 30 minutes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
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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 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.
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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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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.
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