GINA, in the works for two years, has passed the House and been approved by the Senate Health Committee; it is being kept from the floor by members concerned over the number of lawsuits it could unleash.  SCHIP now covers some six million children whose parents, while low-income, do no qualify for Medicaid.  The bills under consideration would add another six million (Senate) or 7 million (House); both chambers look to increased tobacco taxes to fund most of the expansion.

Appropriations bills had the following scorecard as of adjournment.  Number of Bills:
            a) through House (committee and floor): 1
            b) through House, and Senate committee (but not floor): 10
            c) through both House and Senate and awaiting Conference reconciliation of differences: 1
            d) through both House and Senate, and Conference, and sent to the President: 0.

The Health & Human Services Department appropriation measure is in group b, where almost all other bills are. This scorecard is roughly on-schedule for this point in the session, but means there will be considerable pressure on the Senate leadership in September to take up the 10 bills awaiting floor vote there, despite a full plate of other bills awaiting floor action.  As the new House Democratic majority has been more activist than that in the Senate, where the majority is the slimmest possible – one vote – it is likely the Senate will not accept many terms of the predictably more generous House-passed bills, creating contentious votes as well as pressure on Conference committee members to reconcile differences and send bills to the President in time to keep the lights on in government buildings after the October 1 beginning of Fiscal Year 2008.  In fact, just before adjournment Harry Reid (D-NV), the Senate Majority Leader, indicated the almost certainty that some or all of these money bills will be bundled together, as has been done many times in recent years, into an Omnibus-type bill. Such bills risk little control of earmarks and otherwise put some of the appropriations provisions at greater risk of ‘midnight manipulation.’

The main appropriation of interest to the hemophilia/AIDS/HCV community is the Ryan White Care Act, the $2.2 billion dollar federal program for AIDS care and support.  The House gave it a greater increase than the President’s request, but it still amounted to only a 4% improvement.

The House and Senate, as mentioned in COTT’s Washington Alert on July 18^th, were expected to Conference their two very different versions of the Prescription Drug User Fee Act (PDUFA), continuing the heinous practice of allowing the drug industry to underwrite the government’s reviews and licensure of drug industry products, among other things. 

Conference has been delayed until September at the earliest, as the Senate has been reluctant to accept the stronger consumer protections found in the House language.  Since action on this bill may not be final until after October 1, considering the press of other business on the Hill in the fall, the FDA has begun steps to give notice of its intent to lay off, effective October 1, staff of its new-drug review operations.  Congress was asked in the spring to consider, pass, and seek enactment into law as early as possible in the year to avoid such layoffs and the risk they pose of losing these employees, who may be tempted to join industry and thus not available for rehire.  (FDA may use some version of a tactic just revealed in Hill testimony from recent years: the brighter the spotlight on the agency for inadequate safety protections, the more its top staff were being given bonuses – sometimes several times their salaries – if only they would sign a form indicating that if they didn’t get the bonus, they would be tempted to leave the agency and join industry. We don’t think the review staffers are being offered bonuses to sweeten the bitter pill of imminent layoffs, but who knows?)

There are good honest scientists at FDA who strive to operate an effective regulatory agency. There are more there who make it harder each year to tell where the agency stops and industry begins.  While more ample appropriations from Congress would allow the agency to get away from dependence on industry, expecting Congress to prioritize raised appropriations for an agency presently characterized as so pro-industry and with such poor effectiveness and morale is probably too much to ask – who wants to enlarge an agency so problem-ridden as that, in the name of regulatory oversight?

The MediGap coalition conducted another two-day Hill ‘blitz’ with several teams making visits. In the House, targets were Members not yet signed on as co-sponsors; in the Senate, more visits were scheduled than ever before in search of an original sponsor for a companion bill to HR 1282.  Scheduling this round after members had left for the August recess, we found staff much more available and willing to go into the issues in longer visits.  The estimate of the cost of the program (and how much less the cost would be if fewer groups were covered) has not yet come in from the contractor.  By the next ‘blitz’ in late September we should have that estimate or ‘score’ in hand and it should hopefully ease some concerns that have been keeping members from co-sponsoring.

> AGENCIES

Both federal advisory committees – Blood Products Advisory Committee (BPAC) of FDA, and the Advisory Committee on Blood Safety & Availability Committee (ACBSA, or BSAC) in the Office of the Secretary, HHS, are meeting in August, traditionally a time of little government activity in Washington.  BPAC’s meeting covered a review of World Health Organization standards for blood and blood products, and a discussion of measles antibody levels is US immune globulin products.  BSAC, in its second meeting since its charter was expanded by the Secretary to include organ and tissue transplantation, will review ethical and risk considerations concerning these, and transfusion, during shortages.

COTT has alerted FDA to a press article (attached at the end of this Update ) detailing the operation in Texas of a number of pheresis (plasma collection) centers close to the Mexican border – even providing busses from the border to the center and back. They typically pay border-area Mexican citizens with tourist visas $25 for the first donation of a week and $55 for a second: many clients make more money in this manner than through their jobs.  The Treasury Department is considering revoking these tourist visas since making money violates the terms of such visas.  The companies deny any wrongdoing. All have approached COTT since the article was circulated; PPTA has rushed to print a Press Release that nevertheless uses the word “donor” 25 times in 1 ½ pages to refer to those paid for their blood.  There seems to be a complete ignorance of the risk blood recipients face because industry creates a situation where, desperate for money, people will gladly lie on intake about their diseases and behavior, to guarantee they are accepted – and paid.

> INDUSTRY

On August 7 the California Department of Managed Health Care held a Public Hearing on the implementation of a series of changes resulting from the merger three years ago (but only taking effect this fall) of Blue Cross Anthem and Wellpoint health insurance programs.  Until recent weeks it appeared the decision had been made to use a sole provider for hemophilia.  Since that time it is our understanding this provider list has been expanded to include any 340b Hemophilia Treatment Center.  COTT President Corey Dubin provided the following testimony at the meeting:

We view the recent decisions by Anthem Blue Cross to dramatically, and unilaterally alter the delivery of healthcare for its hemophilia and bleeding disorder clients to be another example of poor decision-making for a disease community that is still recovering from the AIDS/blood epidemic. … We are troubled and concerned that the State of California would allow that structure to be cannibalized in the name of Anthem/Blue Cross/Wellpoint profits.  The degree of vertical and horizontal concentration of medical decision making in the hands of Anthem/Blue Cross/Wellpoint represents a direct threat to the gains made by the hemophilia community in the wake of the AIDS/blood epidemic.  … Hemophilia falls in the area of rare and expensive disease states. The proactive application of treatment and services, rooted in positive patient outcomes, has significant benefits in terms of persons with hemophilia remaining productive citizens …

In other testimony, the Foundation for Taxpayer and Human Rights, pointing to violations by the companies in the agreed-to terms of the merger,  said:

..[B]etween 2004 and 2006, BCC has made monetary transfers to affiliated companies in the form of dividends and so-called “management and service agreements” that exceed the amounts allowed by the merger agreement by up to $6.5 billion. Such transfers may be laundering profits that exceed the legal limit established in the merger agreement … Overly aggressive underwriting practices and refusal to pay medical bills in conjunction with illegal cancellations of coverage produce profits that greatly exceed the anemic financial penalties issued by the Department in the past  … Internal Blue Cross underwriting documents revised one month prior to the merger approval show that BCC now regularly refuses to sell coverage at any price to people with minor health conditions like Acne, Arthritis, and Asthma.

While persons in the hemophilia community in California are being contacted that they will be assigned new providers (and hence possible limitations on choice of product) as of September 1, just around the corner, the testimony by COTT, the Taxpayer group, and others at this hearing have sent a clear warning shot that the state must heavily redouble its monitoring of these companies’ past, present and future activities, particularly with regard to this merger.

> The Loss of an Another Young Brother by Corey Dubin

The calls came in this morning, the question, “are you sitting down,” and  the realization that another life has been taken. Another vibrant young man, struck down in his prime, broken by the ravages of blood borne virus, HIV and hepatitis C, transmitted through the blood products he used to treat his hemophilia. Sacrificed for greed and profit, expended like a commodity by the pharmaceutical manufacturers who chose profit and market share over human life in the 1970s and 1980s. By government bureaucrats who failed to protect those who depended on the Food & Drug Administration to ensure the safety of our nation’s blood supply.

Marcus McClure, a name I want to place in grace with an exclamation point, many exclamation points. A vibrant and alive young man, who could stop you dead in your tracks with his hip hop/rap songs about the pain and suffering of living through the preventable HIV/AIDS and hepatitis C infection of an entire community. His music was truth and he was never afraid to definitively state that truth in his songs. He touched those that took the time to engage him and left a strong impression on all those who interacted with him. Marcus was a complex young man, always looking to be hopeful, while not hiding from the truth of the dual time bombs of HIV and HCV ticking inside Marcus and all of us still surviving.



Marcus and my daughter Kaile developed a strong bond over the last two years and through that bond both Marcus and Kaile were deeply impacted by what occurred in our community Both Marcus and Kaile were representative of those in our community infected and those affected, daughters, mothers, fathers, sisters and brothers, reflective of the pain and loss as well as their response to the nightmare, rooted in empowerment and dignity. Marcus had hope, hope for himself and hope for the future of our community.

Marcus authored specific songs about his experience with being devastated by tainted blood products and the righteousness of the struggle to gain justice and accountability. Marcus McClure exuded life and a love of life. He loved his immediate family as well the larger community family. His music captured critical aspects of the shared experience we have labored through in the hemophilia community. He spoke clearly to what really occurred and why so much suffering has been visited upon our community.

To the McClure family, Greg, Diane, and Greg Jr., we extend the love and respect of our entire organization and Board. Our condolences for the loss of your son, brother and best friend; we too will sorely miss this unique young man. In the name of Marcus McClure we again state our commitment to continue working on behalf of those surviving HIV/AIDS and HCV in our community. Marcus provided us with words of truth and we will not forget that truth or all of our brothers and sisters, and mothers and fathers, who have passed into the spirit as a result of the AIDS/Blood and HCV epidemics in the hemophilia community.

To Marcus, may your journey into the spirit world be safe and loving and filled with a new kind of joy.

Marcus McClure Presente’.

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

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