| Posted by
Dave Cavenaugh 07-30-2008 |
WASHINGTON UPDATE |
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July, 2008 Vol. 10 No. 6
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> STATE-LEVEL ISSUES .
The California Legislature continues to grapple with the Governor’s proposed across-the-board cuts for the fiscal year which has just begun (as of July 1). The Legislature acceded to the Governor’s requests in the spirit of looming crisis and enacted these cuts in February, shortly after they were proposed. Much work has ensued between then and this month to modify them substantially. It appears that the will has been expressed, in both chambers and across both parties, to seek a moderation of the cuts, although some debate persists as to the source of the revenues to make up the savings if certain programs are not cut. COTT continues to work closely with the Hemophilia Council of California as matters proceed over the summer. COTT President Corey Dubin has been appointed to the Advocacy Committee of the Southern California Hemophilia Foundation, known as SoCal, earlier this month. This presents broadened opportunities for coordination between COTT and local, grass-roots organizations as the budget crisis unfolds.
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The California situation, while clearly the biggest crisis in terms of proposed cuts, and arguably the first of the state crises unfolding as the economy tightens, is by no means the only problem state needing close attention by advocates in the hemophilia community. The National Conference of State Legislatures (NCSL), and the Washington-based Center for Budget and Policy Priorities (CBPP), a think tank highly respected for its fiscal analyses, both published reports this spring on the number and types of fiscal crises being faced at the state government level. NCSL found that 23 states are facing shortfalls in their FY2009 budgets, totaling some $26 Billion; CBPP found the number to be 27 states, for almost $40 Billion. .
According to NCSL, the states in the worst situations, following California, were: Florida and New Jersey, followed by Arizona, Massachusetts, Minnesota, Nevada, Ohio, and Virginia. COTT has begun building campaigns in these states to identify the timing, key decisionmakers, and health program threats, and to begin building action plans for state hemophilia communities’ use. .
The NCSL annual meeting in July proved to be a major source of information on health program crises in these and other states, and generated a number of contact leads for our community’s use in developing such campaigns. Over the next several years the community must focus on state issues more than ever as the crisis will continue in state capitals across the nation.
. > CONGRESS
. In early July House and Senate leaders announced a commitment that the Congress would not reconvene after the November elections in what has come to be known as a “lame-duck” session. If this comes about it will be the first time since 1996 this was attempted. They also announced a projected adjournment date of September 26th, not even a month after they return from the traditional month-long August recess. What is sacrificed to achieve such a shortened schedule is all thirteen regular appropriations bills, which would be ‘punted’ into next year, with a catchall giant Continuing Resolution bill adopted in September to keep the government in operation. Leaders may feel the money bills will fare better come January if there is a change of party in the White House, but the challenge will be appropriating for two years at once. And funding a war.
. Legislation to raise lifetime health benefits caps was introduced in the House July 18th, as companion (identical) language to S. 2706 in the Senate, introduced in March. The House bill, HR 6528, is sponsored by Rep. Anna Eshoo (D-CA); the Senate measure by Sen. Byron Dorgan, (D-ND). Although no co-sponsorships have been secured for the Senate bill, introduced in March, there have been strong indications from five to ten House offices of interest in co-sponsorship there; three came on the day of introduction as original co-sponsors (Jason Altmire (D-PA), James Langevin (D-RI) and Betty Sutton (D-OH)). Consumers whose Representatives or Senators sit on the key committees for these bills are urged to contact them to support for the bill by co-sponsoring them. Lists of these Committees’ members are included as Attachment #2 to this Update. .
U.S. support for international AIDS relief has grown massively in both funding and visibility since legislation first passed in 2003. The program, known as the President’s Emergency Program for AIDS Relief (PEPFAR), has been hailed as one of the current President’s greatest achievements. Currently funded at a level of $6 Billion, it provides services to 1.7 million persons worldwide. Efforts to renew and expand it, however, have proceeded in fits and starts over seven months this year, held up now here and now there by members who wanted various program aspects specified more rigorously. For example, Sen. Tom Coburn (R-OK), an M.D., held up the bill in the Senate until a provision was added that (as now required in domestic AIDS programs funded under the Ryan White CARE Act) more than half the program’s international AIDS support go towards treatment and care (vs., for example, prevention education). Another concern was the outcry over the previous bill’s requirement that any organization receiving funding, and many were not US-based, stress abstinence over any other method of HIV prevention and spend 50% or more of funds on abstinence program. That has been softened, but not much, to a requirement of 1/3 spending for abstinence – but requires a report to Congress from any country in which such spending falls to less than one-half. Finally, the new bill repeals a longstanding ban on foreign visitors to the US who are HIV-infected: this is the reason the World AIDS Conferences have never been held in the US. Our nation continues to be global leaders in the development of new approaches to treatment. However we remain in the dark ages regarding this onerous ban on travel to the US for those who are HIV infected.
. Two billion of the total authorized funds figure are for the first time allocated for programs for American Indians; other portions go toward tuberculosis and malaria relief, as these co-exist with AIDS in many high risk areas and are much more dangerous for those with AIDS. As the bill is finally crafted and goes to the President for signature, it authorizes far more funding than is likely to be appropriated any time soon. The current bills’ language permits $48 Billion to be appropriated (well above the President’s request of $30 Billion doubling the $15 Billion authorized in 2003), but current appropriations bills carry only $5 to $6 Billion for these programs.
. . > AGENCIES
. As the Presidential election campaign goes into high gear you may find the occasional story about it here, under Agencies: the President heads the Administration, where administrative agencies are. This month the Democratic Platform Committee held field hearings in many communities; COTT presented issues for its consideration at a California meeting. These included increased funding for and oversight of the FDA in new drug application review, post-approval surveillance, direct-to-consumer advertising crackdowns, and other areas (including importations and food safety); the importance of raising lifetime caps for those plagued with high-cost diseases, and how little it affects overall insurance to do so; and support for increased federal oversight of the insurance industry -- traditionally state-regulated but flagrant abuses currently abound in nationwide operations, such as sole-provider pharmacies and 50% co-pays for $100,000/yr. drugs.
. Further opportunities are being sought to both lay these issues before the candidates, for public response, and to see them included in the thinking going into the creation of Transition Teams, the small policy groups under the President-elect which will develop plans and re-structuring to make the new policies become reality after the Inauguration.
. An international issue regarding Mad Cow has implications for food safety and blood safety in the US. For two months citizens of South Korea stormed the streets, sometimes violently, in protest over the new President’s lifting of the ban on importation of US Beef. The ban was imposed after the first US case of Mad Cow disease was detected in 2003. South Korea is the third largest importer of US beef, so the ban hurt the US industry. But when in April newly-elected President Lee Myung-bak announced to President Bush on a visit to Washington that the ban was lifted, as a political gift, the news was greeted with great animosity at home. Truthfully, much of this was over the new man’s style, which was seen as distant. “Giving in” to pressure from the US, however, was seen almost as high treason. There is in Korea a fundamental suspicion of all larger powers, especially (from past experience) those surrounding it, and by extension the US. .
The beef issue is part of a larger trade agreement, nearly worked out, which would boost sales of Korean products abroad – needed as the increasingly-well-respected products of auto companies there are in demand in the US and elsewhere. The protests – which escalated to injuries to scores of police and protesters after some of the demonstrations – have little to do with Mad Cow disease itself. Modifying the beef agreement to include only cattle of under 30 months of age – often used as a benchmark to separate cattle least likely to be infected – has not mollified the crowds. The US trade agreement negotiator, US Trade Representative Susan Schwab, was under pressure from home not to agree to this added protection, but she was clear that only the reduced plan would help solve Lee’s problems. US Secretary of State Condoleeza Rice added Korea to a Far East trip recently, but when she said the US position was designed to help improve Koreans’ confidence in US beef, the response from the street was that this was a patronizing insult.
. Given the degree of rancor it is surprising that no data about Mad Cow cases in the US has been brought to light – or, once further removed, human deaths in this country related to the disease. Protesters in Korea apparently know better than US residents how inadequate the Department of Agriculture surveillance efforts in place really are. Schwab even offered to include in the new plan regular inspections of US slaughterhouses by Korean scientists. This did not appease the opposition, but it might double or triple the amount of actual surveillance here.
. . Another agency-related story concerns recent articles on the American Red Cross (ARC), its $20 million in FDA fines in the past five years for poor blood quality management, and the total twenty-five year period during which it has been under a court-ordered “Consent Decree” for such matters. In an article on July 17th and an accompanying editorial two days later, the New York Times excoriated the unwieldy and too-decentralized organization: “The organization’s sloppy procedures and its lethargy in investigating possible harm have put untold numbers of Americans at risk.” More specifically, “The most frequent errors cited by FDA investigators involve failing to ask donors questions that would reveal their ineligibility to give blood…Blood collection is also error prone.” The article can be found at the link below.
. According to the FDA, “the Red Cross has repeatedly failed to investigate the results of its mistakes, meaning there is no reliable record of whether recipients were harmed by the blood it collected.” Hard to imagine considering that the Red Cross controls over 40% of the nation’s blood supply.
. The blood services side of the organization heavily subsidizes much of the agency’s disaster relief work. Yet, according to former Red Cross Director Bernadine Healy, previously head of the National Institutes of Research, “When was the last time you saw a fund-raising appeal for money to make the blood supply safer?” One Red Cross employee, previously at the FDA, described how it took six months for the Red Cross take action regarding 600 units that he discovered were collected improperly. The employee was fired. The units were eventually ‘recalled,’ 14 months after their release – long after they would have been used. No one knows if they harmed any recipients – as indicated above, no such records are researched, reported or retained. This does not mean that no harm occurred. Consumers and their providers are unlikely to trace adverse events to a transfusion. Unless of course they contract a virus….
. . > COALITIONS
. COTT is pleased to have established links with the Southern California Hemophilia Foundation, as mentioned earlier, and has also developed effective linkages elsewhere in the country, including with the New England Hemophilia Association. We were pleased to have been able to participate in several interactive discussions among chapters and organizations concerning the Red Cross.
. The Center for Safe Blood and Healthcare, a New York consumers group, has submitted to FDA a detailed request for information (under the Freedom of Information Act) concerning the regulations in place to assure the safety of manufacture, transport, storage and final distribution of both plasma-derived and recombinant factor. They have since begun preparations for a subsequent request to the agency, concerning the abuses of blood safety in the 1990s by the New York Blood Center. COTT has been pleased to consult with them on both of these projects, wishes them well, and is eager to learn of the responses they receive.
. . BLOOD SAFETY SUMMARY
. Concerns over raised disease risk from importation of US beef continue in Korea, far in excess of any manifestations of concern over US beef here. The New York Times took the American Red Cross to task for dangerous procedures, a near-complete lack of followup in cases of release of blood with compromised safety, and a willingness to add more fines to the $20 million it has paid to date for infractions, versus putting in place fundamental overall reform of the system.
. The continuing abuses of the American Red Cross in releasing products that failed testing, with no followup, were detailed in a New York Times story and editorial.
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
July 16, 2008
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1182-08
CODE
Units: 9624568, 2150538, 9624353, 9624918, 9624845, and 2147690
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by telephone on August 8, 2007. Firm initiated recall is complete.
REASON
Blood products, mislabeled as crossmatch compatible, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
CO
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PRODUCT
Red Blood Cells, Recall # B-1459-08
CODE
N25603
RECALLING FIRM/MANUFACTURER
Virginia Blood Service, Inc., Richmond, VA, by letter dated June 19, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
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PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1470-08
CODE
Units: LC81808, LC16818, LC52391
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by facsimile on December 11, 2004. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the Human Immunodeficiency Virus (HIV), but were collected from a donor who was previously deferred for testing positive for HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL, NY and TX
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PRODUCT
a) Red Blood Cells, Recall # 1548-08;
b) Fresh Frozen Plasma, Recall # B-1549-08
CODE
a) and b) Unit: 6736710
RECALLING FIRM/MANUFACTURER
The Blood Centers of New Jersey, East Orange, NJ, by telephone on August 30, 2005. Firm initiated recall is complete.
REASON
Blood product, incorrectly tested for West Nile Virus, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 components
DISTRIBUTION
NJ and SC
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PRODUCT
Source Plasma, Recall # B-1550-08
CODE
Unit: DQ038692
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Johnson City, TN, by fax on August 30, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose physical exam was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
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PRODUCT
a) Red Blood Cells, Recall # B-1558-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-1559-08;
c) Cryoprecipitated AHF, Recall # B-1560-08;
d) Cryoprecipitated AHF, Pooled, Recall # B-1561-08;
e) Frozen Plasma, Recall # B-1562-08
CODE
a) Units 40GF81982, 40GF81991;
b) Units 40GF81990, 40GF81994, 40GF82008, 40LT29239, 40LT29295,
40LT29341, 40LT29361, 40LT29218, 40LT29232;
c) Unit 40LT29239;
d) Pool 2010 - unit 40LT29218;
e) Unit 40GF81982
RECALLING FIRM/MANUFACTURER
American National Red Cross HOA Blood Services Region, Peoria, IL, by fax on February 5 and 6, 2008. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
IL and MO
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PRODUCT
Platelets Leukocytes Reduced Irradiated, Recall # B-1574-08
CODE
Unit: X53234
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Inc., Richmond, VA, by telephone on November 28, 2006 and letter dated December 8, 2006. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined after receiving information regarding a post-donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
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PRODUCT
Recovered Plasma, Recall # B-1576-08
CODE
Unit: 4406554
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Alexandria, LA, by electronic mail on May 18, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
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PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1577-08;
b) Recovered Plasma, Recall # B-1578-08
CODE
a) and b) Units: N61989
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Inc., Richmond, VA, by letter and fax on October 13, 2007. Firm initiated recall is complete.
REASON
Blood products collected from a donor considered to be at increased risk for variant Creutzfeld-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ and Vienna, Austria
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PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1600-08
CODE
Unit: 197529692
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Reno, NV, by letter dated January 3, 2005 and March 11, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor using an abbreviated screening process for which the donor was not eligible, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NV
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PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1583-08
CODE
Unit: LT28475
RECALLING FIRM/MANUFACTURER
Tri-Counties Blood Bank dba UBS Central Coast, Ventura, CA, by letter dated July 25, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was receiving Factor VIII medication, was distributed.
[ emphasis added ]
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
Attachment #2: Congressional Committee Members to Contact for Support of Lifetime Caps Legislation
. Bill Numbers & Sponsors:
Senate: S. 2706 Sen. Byron Dorgan (D-ND)
House: HR 6528 Rep. Anna Eshoo (D-CA)
. Senate Health, Education, Labor and Pensions Committee
Democrats
Edward Kennedy MA Chair Christopher Dodd, CT Tom Harkin, IA Barbara Mikulski, MD Jeff Bingaman, NM Patty Murray, WA Jack Reed, RI Hillary Clinton NY Barack Obama IL Bernie Sanders VT Sherrod Brown OH Republicans
Michael Enzi, WY Judd Gregg, NH Lamar Alexander, TN Richard Burr, NC Johnny Isakson, GA Lisa Murkowski, AK Orrin Hatch, UT Pat Roberts, KS Wayne Allard, CO Tom Coburn, OK .
House Energy & Commerce Committee Subcommittee on Health
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Democrats
Frank Pallone NJ Chair Henry A. Waxman, CA Edolphus Towns, NY Bart Gordon, TN Anna G. Eshoo, CA Gene Green, TX Diana DeGette, CO Lois Capps, CA Tom Allen, ME Tammy Baldwin, WI Eliot L. Engel, NY Jan Schakowsky, IL Hilda L. Solis, CA Mike Ross, AR Darlene Hooley, OR Anthony D. Weiner, NY Jim Matheson, UT Republicans
Joe Barton, TX Nathan Deal, GA Ralph Hall, TX Barbara Cubin, WY John Shadegg, AZ Steve Buyer, IN Joseph Pitts, PA Mary Bono, CA Mike Ferguson, NJ Mike Rogers, MI Sue Myrick, NC John Sullivan, OK Tim Murphy, PA Michael Burgess, TX .
House Education & Labor Committee Subcommittee on
Health, Employment, Labor, and Pensions
Democrats
Robert Andrews, NJ
George Miller, CA
Dale Kildee, MI
Carolyn McCarthy, NY
John Tierney, MA
David Wu, OR
Rush Holt, NJ
Linda Sanchez, CA
Joe Sestak, PA
David Loebsack, IA
Phil Hare, IL
Yvette Clarke, NY
Joe Courtney, CT
Republicans
John Kline, MN
Howard P. “Buck” McKeon, CA Kenny Marchant, TX Charles W. Boustany, Jr., LA David Davis, TN Peter Hoekstra, MI Cathy McMorris Rodgers, WA Tom Price, GA Virginia Foxx, NC Timothy Walberg, MI
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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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