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The rise in genetics science, and the sure-fire attraction to the public of any even quasi-scientific means for predicting individual ‘propensities’ for specific diseases, disabilities, or even traits, has created a wealth of opportunities for unscrupulous new “labs.” And that's just for those who want to test themselves, never mind for the moment commercial buyers who want to test applicants and so on.

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The dangers that the advent of general genetic testing holds for persons with chronic conditions are substantial. Testing ability is way ahead of the knowledge base. That is, telling who may have future issues with a particular condition or disease, by drawing from the scant existing genetics research knowledge base, is still very difficult.  Most of the genetic code is still unmapped as far as the ability of permutations of individual components to trigger future concerns.  Longitudinal studies to confirm such links just have not had time to take place as yet.

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When employers and insurers begin to purchase testing operations, there is too great a chance that they will contract, perhaps unknowingly, with businesses operating at a low level of integrity; to some extent they may be typical of the industry at that stage in its growth.  Hopefully fraudulent practices will trigger reforms and oversight, and the enforcements of GINA will come about swiftly, but both may take time and many may be hurt.  In sum, while the description of the law says it will prohibit genetic discrimination in health insurance and housing, it really won’t – for some time, if ever.

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Follow-on (Generic) Biologics

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Several pieces of legislation developed under rapid, bipartisan interest last year in the first session of the current Congress, such as H.R. 1956, introduced by Rep. Jay Inslee(D-WA), are still under study; but they seem to have stalled. COTT became alarmed to hear early on of support for these measures by House and Senate health leaders, as there seemed to be little concern to protect blood products from low-cost, “almost as good,” generic substitutes.  Between then and now, however, protection for biologics (including blood products) have been added, reducing fears concerning the development of such future generic forms of factor concentrates.  Prospects for passage of such legislation this year are slight at best.

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Medi-Gap

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Nine additional co-sponsors have been added to HR 1282 since March 1, almost half the direct result of NHF Washington Days visits by community members.  The current total of 53 is  good considering the slow pace of additions since introduction in this Congress a year ago, but only enough to be barely on the radar screen of leaders who can speed the bill’s committee and floor consideration.  Although a formal “score” – calculation of the costs to the government if the bill becomes law – has not been requested of or issued by the Congressional Budget Office, a privately-funded ‘shadow’ score developed last year showed that the cost would far exceed the estimates of the bill’s supporters, due to large numbers of enrollees.

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It is this high score – almost two billion dollars over its first five years – and the lack of a mechanism provided in the bill to pay for those costs, which has deterred more members from giving their support to the measure.   

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Lifetime Caps

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The three national hemophilia groups which now have a permanent Washington presence met in early May with a potential House sponsor of the Lifetime Caps legislation that has been introduced in the Senate, and will continue to work together on the several aspects of seeking passage for this key legislation. For example, a search is under way to have sponsorship of the bill be bi-partisan. Stay tuned.

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State Issues: California

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COTT participated in activities to raise the alarm over the seriousness of the major cuts in state health programs in another month.  We presented at the Family Day held by the Hemophilia  Foundation of Southern California in Los Angeles on April 26 concerning the crisis, distributing sample letters for the community's use in contacting legislators.  We were instrumental in organizing a press conference about the crisis on April 28 on the steps of the hospital in Santa Barbara, CA, co-presenting with representatives of the Women's Political Committee, Health Care for All, Pacific Pride, and the local pulmonary hypertension community, and host Santa Barbara City Councilman Das Williams.  Both print and electronic media participated, and news stories from the event appeared in both, later that day and for several days following.  COTT has been active in keeping the pressure on, working with other disease groups (Pulmonary Hypertension, AIDS).

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In a surprising twist to the California budget campaign, it was learned in late May that language had been included in the new cost and program description estimates released by the Governor that month.  The state’s main hemophilia assistance program is the Genetically Handicapped Persons Program, which currently provides over $50 million each year to aid persons with hemophilia.  The language in question would authorize the office administering that program to sign an exclusive contract with a provider (pharmacy) of clotting factor.  The language permits this action, it does not require it.  However, community advocates fought doubly hard as the threat of exclusive or sole source factor contracts was imminent. Both the full Senate Budget Committee and the Assembly Budget Subcommittee #1 met on Friday May 30 to finalize the trailer language that accompanies the budget.

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The Senate Committee specifically directed the Department of Health to “adopt placeholder trailer bill legislation that would 1) Contain a three-year sunset to enable a review; 2) Delete any reference to exclusive contracts; 3) Provide for consumer quality of care factors; 4) Ensure a network of pharmacies; and 5) Make it clear that blood factor product choice will not be limited.”

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COTT certainly views this as a victory and acknowledges the hard work of Terri Cowger-Hill and the Hemophilia Council of California. COTTWest has been working closely with the Council, and the Southern California Hemophilia Foundation (SoCal) as well during these difficult times facing our community in California. Certainly there is much more work to be done, however given the many threats to our care and other chronic disease community care as well, this was an important step in protecting the hemophilia/bleeding disorders community in the State of California. Given that numerous States are facing serious to critical budget deficits, this is a drill the hemophilia community will face in numerous state capitals in the coming weeks and months.

Sentinel Initiative

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In a joint announcement by the Commissioner of FDA, the Acting Director of the Centers for Medicare and Medicaid Services (CMS), and the office of the Secretary of HHS on May 22, a project to improve the FDA’s ability to document negative outcomes from prescription drugs already approved and in circulation was launched.  FDA will still keep its passive system for doing this, called the Adverse Event Reporting System (AERS), but its major flaws – it is voluntary, lacks reporting standardization, and cannot screen out factors to which a problem might be attributed other than the drug in question – still massively hamper its effectiveness, despite extensive computer analysis of reports submitted for patterns, etc.  COTT is pleased that the agency is taking this new technology-based step to improve post-market surveillance.  As has been proven time and again, a voluntary system does not suffice.  European countries have a mandatory notification system; providers here at least need specific training on when and how to use AERS.  Under the new system, FDA will generate specific database queries, or questions, seeking such patterns, and CMS will have its contractors which operate the new Prescription Drug component of Medicare search their patient medical databases.  This can be rapid, and large-scale, since many or all contractors can be queried at once.  It is not yet clear however when the program will actually begin generating queries, doing the searches, and producing findings.

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Blood Product Advisory Committee

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The FDA Blood Product Advisory Committee (BPAC) met in early May; topics included West Nile Virus testing, improved screening for Chagas disease, and measures to increase the supply of intravenous and subcutaneous Immune Globulin (IG), a blood product vital to persons with Primary Immune Deficiency and others which has been both in short supply and under-reimbursed for several years, direly threatening patient access.  Regarding Chagas, in last month’s Update we noted that historically the countries with high rates of Chagas were essentially the same as those with high rates of malaria, so the ability of a blood donor screening question about countries of residence and/or travel, resulting in deferral if time was spent in a malaria country, could also be relied on to screen out Chagas.  However, given new data on Chagas incursions into the US directly, from the south, such screenings are thus now arguably inadequate.  (The symptoms are generally mild, although a second infection can be fatal.)
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Data on transfusion transmission from known positives for Chagas showed low rates, which is good news, but moving from just screening to actual testing is impeded by the lack of a federal requirement for testing since Chagas, though infectious, is not classified as a ‘relevant contagious disease’ in the view of the Centers for Disease Control (CDC).  Thus, even the CDC-sponsored clinical data collection program at Hemophilia Treatment Centers does not currently call for routine testing for Chagas.  A CDC representative on the panel noted that efforts could be taken to increase these protections, first in the hemophilia program and then in general in terms of CDC reporting, by reclassifying Chagas to the ‘relevant’ category. 

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Transmissible Spongiform Encephalopathies (Mad Cow) Advisory Committee
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COTT is pleased to announce the appointment of Chris Templin of its Board of Directors to the FDA committee concerned with Mad Cow and related infections.  Templin’s background in farming and his several presentations before the Committee already assure his participation will be vital.

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Advisory Committee on Blood Safety and Availability
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The US DHHS Advisory Committee on Blood Safety and Availability met at the end of May.  Topics included a) transfusion and transplantation negative outcomes, b) contamination of platelets in storage, and c) effects of red cell age when transfused. (The committee recently expanded its charter to add bone, organ, and tissue safety and availability, and its name will be changed shortly to reflect this broader mandate. Oversight of the safety and availability of blood products per se, therefore, one could say, has shrunk in priority to only one-sixth of the issue areas under the committees purview -- even though the committee's establishment eleven years ago resulted directly from the HIV and HCV contamination of blood products some 15 years before that.)  The information about infection, malignancy and death rates following these procedures was disturbing to say the least, although the rates involved may not have been unusually high within that population. The data presented was from studies done retrospectively – well after the time of transmission – as  many such studies are.  The advent of the above-mentioned Sentinel Initiative may aid in better data collection as its ability to seek patterns in large datasets comes to bear.

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The COTT Board has nominated its President, Corey Dubin, to fill the open seat on this important DHHS advisory committee. COTT continues to be an active and participatory part of the ACBSA landscape, as this committee plays an important role in the management of the nation’s blood supply. COTT, largely through the efforts of Mr. Dubin in the mid-1990s, was instrumental in the creation of this Committee, which has a DHHS Department-wide overview mandate.

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Heparin Update
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In last month’s Update we raised questions regarding the inconsistent notification of staff and consumers by providers to the hemophilia community of the news that certain lots of Heparin, produced by Baxter, were contaminated.  While Baxter has completely complied with all requirements that they notify providers, the reported inconsistency, and seeming inability to do anything about it, of how providers then inform patients of recalls has always been frustrating.  The Plasma Protein Therapeutics Association (PPTA), the association of manufacturers of plasma-derived and recombinant analog lines of factor, has for years sponsored a Patient Notification System (PNS) which notifies enrollees rapidly when there is a recall or other FDA notice concerning a given blood product. However, Heparin, although widely used in the hemophilia community for clearing of ports before and after use, is not itself a blood product and so does not trigger the PNS system.   Presumably this would be true for, for example, HIV and HCV medications as well.  Thus it falls to the community to monitor, if such warnings are sounded, that they be announced equitably throughout the community, and that they are accurate.

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Wellpoint

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After a three-month lack of communication from Wellpoint, COTT recently received inquiries from them regarding the burden of co-payments on our community members.  Being somewhat puzzled over the sudden concern on this topic from such a massive company – Wellpoint now insures one in nine Americans, over 10% of us -- we replied at once, but have heard nothing more. 
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We still have no evidence of the nextRx pharmacy program inception in the states forecast earlier this year for May startups – Maine, New Hampshire, Connecticut, New York, Virginia, and Georgia.  Since the program permits participation of 340b HTCs, for now, states where the proportion of Centers which are 340b’s is high may see little change.  COTT is waiting to hear about a new customer service program that we are told Wellpoint has put in place. We have been approached again about starting regular meetings between COTT and Wellpoint and are waiting to be contacted about a first meeting.

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Specialty Pharmacy Issues
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A spate of articles in the Wall Street Journal, New York Times and similar print media earlier in May identified several new trends in Specialty Pharmacy contract procedure. Perhaps the most disturbing was the revelation that several insurers are making use of a new reimbursement category in the Medicare program as of the new Medicare Modernization Act of 2003: Tier 4 Drugs are high-cost drugs for which providers are allowed to charge co-pays higher than 20%, ranging up to 33%, based on the cost of the drug.  That is, if your use of factor in a given month resulted in $5,000 in charges, as it often may, you are used to a co-pay of $1,000.  However, if routinely your costs were more in the $50,000 a month range, you might be held liable for $16,700 every 30 days, not the $10,000 which a 20% cap on co-pays would require, always the limit until now.  As of yet there is  no evidence that this has been implemented in the hemophilia community.  It is mostly aimed at much higher-cost, non-chronic conditions like cancer.  However, a surprising number of new drugs have been approved in recent years which can cost many tens of thousands of dollars per month.  Families with conditions needing them, without secondary co-pay coverage, can expect to be driven out of their homes and worse.

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PPTA Fly-In
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The association of manufacturers of factor held a one-day visit to Congressional offices May 14^th in which COTT participated.  Six different teams made the rounds of appointments, generally targeted on the key committees for our concerns; five of these teams included members of the blood products consumer community (see section on Coalitions, below). Joint visits were made to congressional offices. A key talking point with congressional staffers was the need to protect our community’s access to critical benefits. Legislation discussed included the Medigap and Lifetime Caps bills on which the hemophilia community has been actively working, but also bills that have been introduced on waiving review requirements for newer, generic versions of biologics (blood products excepted), bills to ease the cost crisis in IG, and one to expand the 340b pricing program, among other ways to permit its use for inpatients at eligible hospitals.

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Conflict of Interest Conference
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COTT participated in the last Bayer-sponsored Leadership Conference held by the Bias Group of California (last because Mr. Bias has moved to the east coast to run NHF) in late April.  The conference was comprised of a briefing on relevant laws, discussion of consequences should violations be found, and an open discussion period to review scenarios as might be found in the operation of hemophilia care organizations.
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As noted in the section on Congress above, the national hemophilia groups with permanent Washington offices (with the addition of Kisa Carter to the Hemophilia Federation staff—welcome Kisa!) met with a potential House sponsor of the Lifetime Caps legislation that has been introduced in the Senate, and will continue to work together on the several aspects of seeking passage for this key legislation.

Representatives of five blood-products consumer organizations (COTT, HFA, NHF, Alpha-1 Association, Guillain-Barre Syndrome Foundation and Immune Deficiency Foundation) participated in the PPTA Fly-In (see Industry).  The participation of consumers along with the political weight of the manufacturing organizations produced effective meetings.

COTT participated in the annual meeting of the Hemophilia Foundation of Southern California, giving an overview of the current COTT Policy Agenda, and focusing more specifically on the California Budget Crisis.
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COTTWest organized a Press Conference on this crisis in Santa Barbara, CA on the steps of the local community hospital.  Speakers included representatives of the Women’s Health Collective, Pacific Pride, and Health Care for All, ourselves, and the host for the event, Santa Barbara City Councilman Das Williams.  Print and electronic media were both represented, and news stories ran from later that day through several days (longer on one website), boosting the effectiveness of this general appeal.
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COTT held a Town Meeting at the annual symposium of the Hemophilia Federation of America in Little Rock, AR in early May.  Approximately 50 community members were in attendance, almost all for the entire two-hour session.  Materials were taken out; COTT Sign-up Sheets were filled in. The meeting featured discussion and debate about the critical issues facing our community and again demonstrated the value of the interactive town meeting model that has served COTT and our community so well. COTT is in the process of scheduling more regional town meetings in the coming months as it is critical to hear the needs, aspirations and objectives of the grass-roots hemophilia/bleeding disorders community.
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Issues concerning fair and equitable notification of hemophilia community members about the announced actual or potential contamination of several lots of Baxter-manufactured Heparin remain unresolved.  The fractionators’ Patient Notification System was not used for this alert as Heparin is not a blood product.

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We continue to present as an Attachment to the Update selections from FDA reports on identification of improperly prepared blood and blood products, often only after they have been distributed.  This month’s excerpts contain a number of samples collected for blood product manufacture.

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Committee of Ten Thousand  236 Massachusetts Ave., NE Suite 609 Washington, DC  20002
800-488-2688 * 202-543-6720 fax

___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1358-08
CODE
Units: 18GT20580
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, Mi, by telephone on June 26, 2007 and follow-up letter dated July 10, 2007. Firm initiated recall is complete.
REASON
Blood products, which did not undergo quality control testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI
__________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1360-08
CODE
Unit: 71X15314X
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL, by fax on March 4, 2006.
Manufacturer: LifeSouth Community Blood Centers, Wiregrass Region, Dothan, AL. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0399-08
CODE
Unit: 29GM28404
RECALLING FIRM/MANUFACTURER
American National Red Cross Mid Atlantic, Norfolk, VA, by telephone on September 29, 2006 and letter dated October 12, 2006. Firm initiated recall is complete.
REASON
Blood product, positive for the S-antigen but labeled as S-antigen negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
__________________________________
PRODUCT
Platelets Leukocytes Reduced, Recall # B-1184-08
CODE
Unit: 4849522
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on August 16, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
__________________________________
PRODUCT
a) Red Blood Cells, Recall # B-1341-08;
b) Red Blood Cells (Apheresis), Recall # B-1342-08;
c) Platelets, Recall # B-1343-08;
CODE
a) KT22768, KH62884, FY00023, FT14039, LV81465, LV80477, LV81038,
    FW68633, GR72942, KH63837, KM23706;
b) KM23382 (2 units), KP16385 (2 units);
c) KT22768, KH62884, FY00023, LV81465, FW68633, GR72942, KH63837;
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on December 20, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from donors who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
22 units
DISTRIBUTION
PA
___________________________________
PRODUCT
Red Blood Cells, Recall # B-1345-08
CODE
Unit: T67854
RECALLING FIRM/MANUFACTURER
Rhode Island Blood Center, Providence, RI, by letter dated February 4, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was taking the medication Tegison, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
RI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1346-08
CODE
Unit: 04C13692
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by facsimile on January 26, 2008. Firm initiated recall is complete.
REASON
Blood product, which tested negative for hepatitis, but was collected from a donor who provided post-donation information regarding two previous positive tests for the antibody to hepatitis B core antigen (anti-HBc), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MA
___________________________________
PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1347-08;
b) Red Blood Cells (Apheresis), Recall # B-1348-08
CODE
a) Units: V81524 (2 units), V81468 (2 units), V81471 (2 units), V81496 (2 units),
    V81499 (2 units), V81515 (2 units);
b) Units: V81549, V81560, V81562, V81564, V81955, V83302
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Bethlehem, PA, by telephone on November 8, 2007. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for hemoglobin and hematocrit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
PA
___________________________________
PRODUCT
Source Plasma, Recall # B-1366-08
CODE
Units: JQ042834, JQ042530, JQ042098, JQ041899, JQ041448, JQ041209, JQ040792, JQ040164, JQ038350, JQ037958, JQ037692
RECALLING FIRM/MANUFACTURER
Plasma Biological Services Inc., Jackson, TN, by facsimile on August 14, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was deferred for a history of incarceration, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1371-08
CODE
Unit: 4437492
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on November 27, 2006. Firm initiated recall is complete.
REASON
Blood product, with an unacceptably high platelet yield, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells, Recall # B-1354-08
CODE
Unit: FX04350
RECALLING FIRM/MANUFACTURER
ITxM Clinical Services, Pittsburgh, PA, by telephone on December 13, 2007 and facsimile on December 14, 2007. Firm initiated recall is complete.
REASON
Blood product, mislabeled as to antigen phenotype, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WV
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1357-08
CODE
Unit: 0353754
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on March 12, 2007. Firm initiated recall is complete. 
REASON
Blood product, collected using automated equipment that did not undergo performance qualification following repair, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1363-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-1364-08
CODE
a) Units: 027KK17272, 027KW07210, 027KL17428;
b) Units: 027KN10308, 027LE97826, 027KK17287, 027LP32381, 027KP10831,
    027LY35110, 027KW07225, 027KP10806
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA, by telephone on January 3, 2008 and by letter dated April 2, 2008. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for syphilis and CVM, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
PA, VA, WV