The HIV/AIDS contaminated clotting factor concentrates were manufactured by New Jersey based Armour Pharmaceutical and shipped to Canada for the treatment of hemophilia.

The case mirrored events in the US where roughly 10,000 persons with hemophilia were infected with HIV/AIDS and/or hepatitis C through tainted factor concentrates. What distinguished the Canadian cases however, was that this particular clotting factor concentrate was produced in the late 1980s when the HIV/AIDS blood epidemic was already known to governments, the medical establishment and the manufacturers of blood products, such as Armour. In fact, the product in question was Armour’s first generation, “virally inactivated” blood product and was advertised as safe and free of blood-borne virus such as HIV.  However, the infection of over one thousand Canadians who infused the Armour product to treat their hemophilia quickly demonstrated that Armour’s factor VIII concentrate was not safe and continued to transmit HIV, in spite of the Company’s assurances to the contrary.

The trial was centered on the question of the degree of knowledge about blood borne HIV/AIDS and whether or not Armour, and its vice-president Dr. Michael Rodell, was negligent in shipping this product to Canada to be used by persons with hemophilia.

The charges against the 3 Canadian doctors concerned their role in the importation of the Armour factor concentrate, and what they knew or should have known about its transmission of blood borne HIV/AIDS.

The Justice, in acquitting all defendants, actually praised the actions of Armour, its vice-president and the 3 Canadian doctors who she concluded acted within “the standards of a reasonable person” and did not exhibit a “wanton disregard for public safety” as the allegations asserted, adding that, “On the contrary, the conduct examined in detail for over one and one-half years confirms reasonable, responsible and professional actions and responses during a difficult time.” Justice Benotto concluded, “The allegations of criminal conduct on the part of these men and this corporation were not only unsupported by the evidence, they were disproved.”

Members of the Canadian Hemophilia Society were “appalled at the decision” and stated that Justice Benotto “ignored the factual and documentary evidence” in reaching her decision. They and other critics of the decision asserted that Justice Benotto ignored or chose to ignore key documents that paint a very different picture of the actions of Armour. According to one document obtained by the Philadelphia Enquirer during the mid 1990s, Armour officials debated whether their first generation heat-treated product was in fact free of HIV. The document indicates that there was serious debate within the committee tasked to address these issues inside the company. Armour hired Dr. Alfred Prince, of the New York Blood Center, to test this first generation heat-treated factor VIII product for the presence of HIV; Prince concluded that HIV was present in relatively low levels in the product. The company chose to reject his conclusions and contract with another scientist to test the product. The product was thereafter approved by the company and shipped to Canada.  The rest is history as the majority of Canadian users of this product became infected with HIV/AIDS.

John Plater, a former president of the Canadian Hemophilia Society, stated that, “I cannot understand how the judge concluded that the company and the doctors did a good job.” According to Plater, “What has been suggested here today is that the behavior of the gentlemen involved and the company involved should somehow be lauded.” John Plater also contracted HIV and hepatitis C through the infusion of tainted factor concentrates during the 1980s.

COTT has worked closely with John and other members of the Canadian group over the years, including last year a week-long chance for us to attend their meetings and together participate in the World AIDS Conference, held in Toronto.  COTT President Corey Dubin stated that, “We are dismayed at the decision of Canadian Superior Court Justice Benotto and believe that the Judge must have ignored not only the documentary evidence but also the multi-volume findings from the years of work by the commission on this disaster chaired by Justice Krever.”

As early as 1994, COTT opened its files to the Royal Canadian Mounted Police which led the federal investigation in Canada. We also met with RCMP investigators in California and in our former offices in the Boston area in the 1990s. “We continue to believe that the RCMP did an excellent job and are saddened by the lack of a robust prosecution by the Canadian government,” stated Dubin. For persons with hemophilia in the US, said Dubin, “this is another example of the ability of the companies responsible for the hemophilia holocaust to evade criminal responsibility for their actions in the late 1970s and 1980s.”  We continue to see “criminal behavior on the part of the manufacturers of factor concentrates in the collection, production and marketing of HIV/AIDS tainted factor concentrates in the 1980s”. We at COTT stand in solidarity with our brothers and sisters in Canada who continue the struggle for justice and accountability in this worst medical disaster in US and Canadian history.

“I do not seek revenge, but I want the truth told”, stated James Kreppner a member of the Canadian Blood Services Committee. Kreppner, a person with hemophilia also infected with HIV and hepatitis C during the 1980s, called the decision a travesty and “vowed to continue to struggle to see the truth illuminated.”
 

> CONGRESS

Rushing through September and October as though it would help them leave town sooner, Congress has been trying to break some of the logjams preventing major bills, and most all annual money bills, from passing.  These include SCHIP -- the Medicaid-based Child Health Insurance bill – despite a lowered cost House-Senate compromise, vetoed and without the votes to override the President; PDUFA – the Prescription Drug User Fee Act allowing requiring Big Pharma to pay FDA to review its drug applications, of which more below; and, further afield, consumer protection laws, Iraq Iraq Iraq, and the energy bill, farm bill, and surveillance legislation.

Absent from the rush to passage is GINA, the genetic nondiscrimination bill, which sailed through the Senate once before and the House this year but is stuck in the Senate now.  Also absent is the immigration bill, which filled headlines from April to June of this year but died over partisan disagreements, and the Congressional Ethics law, developed in January by the new Democratic majority but delayed and weakened in the Senate … nevertheless signed into law in September.

Congress did not pass appropriations bills for all federal agencies by the time current ones expired, September 30; they instead are using a familiar two-part alternative: 1) pass a Continuing Resolution (CR), to keep agencies operating at prior year levels, for only a month or two, to force passage of:  2) an Omnibus appropriations bill, wrapping together spending bills for a number of agencies into one must-pass fast-track larger bill.   Just on October 23^rd the Senate passed the appropriations bill for the Department of Health and Human Services and two others.  Once reconciled with the House version (passed in July) in a Conference committee, the bill would be ready to send to the President.  However, he --fresh from his veto of the Childrens’ Health bill -- is poised waiting for it with his red veto pen:  he is on record declaring he will veto any appropriations bill that exceeds his dollar target for reductions in spending.  Accordingly, Congressional leaders may not send it to him although ready, but wait for passage of other spending bills, and bundle them into the familiar format of an Omnibus bill, much harder for the President to veto as it would risk shutdown of the government as we saw 11 years ago. Stay tuned.

The PDUFA bill was finalized, with great difficulty, on a slightly earlier timeline than most legislation, because if it were not renewed by September 30, several thousand federal employees at FDA would have to be laid off, and they are entitled to notice.  It was signed September 29^th.

The final sticking point on PDUFA was language in the Senate bill making it harder for patients to sue over drug reactions – drug companies would not have to put warnings on their products’ labels unless the FDA were to require it, meaning thousands could get sick, costing millions, but the drug company, despite knowing of the dangers, could use lack of FDA action as a defense.  The provision was removed, in exchange for removal of language in the House bill making it easier for patients to sue.

The new bill grants authority to FDA to order manufacturers to commence after-approval drug trials if field reporting suggests it is warranted.  Previously the agency was only able to request such trials, which were though seldom done.  Also, FDA will monitor television advertising more closely. Finally, the agency will begin reducing the number of expert Advisory Committee members with conflicts of interest, cutting current allowable levels by 25%.

The Disability MediGap bill, HR 1282, a project of a large coalition extending well beyond the hemophilia community, continues to receive substantial support.  Two-day ‘blitzes’ – 10-15 persons visiting offices of key committee members and others – were held in August and this month.  A draft “score” was developed under a contract paid for by CSL, Baxter, HHS and other interested parties, to anticipate such a score which would be developed by the Congressional Budget Office in due time.  Made available in early September, the calculations used in developing this score indicate that, while the costs of providing MediGap insurance to disabled blood-product users would be under $30,000 total in 2008 (including the cost of the services rendered), the costs for others who could seek coverage under such a bill – estimated by the analysts at around 200,000 persons -- could balloon its overall costs to just under $200 million in the first year, and well over a billion dollars over five years.

These large cost numbers, not unexpected, have caused a number of Hill offices to shy away from co-sponsoring the bill.  The current list – 41 – is well short of, say, a third of the House (145), which is the kind of number needed to show leadership a bill has support and should be brought up and voted on in committee and on the floor.  A lower score, whether attained through revised calculations or by a change in the language of the bill, would greatly increase the measure’s likelihood of support and, hence, passage.

An increase in base funding for HTCs has been included in the House’s version of this year’s Appropriations bill for Health and other agencies.  Letters have gone out to Senators’ offices to ask that the Senate accept this item in the final, conference committee bill.  COTT has stood for increases in base support for HTCs for years, not losing sight of the total funding that would be needed to operate all current HTCs without their having to seek other funding, an amount not too far above current funding levels.  This development, if it bears out, is a much-heralded step in that direction – and the first increase in HTC funding in over a decade, while their caseload has doubled.

> AGENCIES

As reported here last month, blood-products manufacturers are collecting plasma near the US/Mexican border from non-US citizens (or even residents), for use in producing what is labeled as US-sourced products.  COTT has presented this matter to both the FDA Office of Blood and to the HHS Secretary’s Office of Blood Policy & Programs.  The industry association and the owners of these centers have communicated with COTT; Meetings with FDA are continuing. It is our understanding that one manufacturer is withdrawing from the association over the language in its response statement concerning this matter.  This manufacturer notes it has no questions about the safety of the product, but it does question the ethical position the association takes.  The two main players in the Texas string of centers have taken umbrage with the member threatening withdrawal, one offering to resign if the first complainant doesn’t.  COTT has been invited to visit the pheresis center in a town three hours from Washington, presumably just to observe the pheresis operation.  What bearing this has on its collecting non-citizen, non-resident blood is unclear, but we are likely to go. 

Four COTT representatives met with eight FDA Center for Biologics Evaluation and Review (CBER) staff on October 16 on this matter.  We were told, first, that FDA has looked into the safety records of Mexican-border-area pheresis centers across several states and found no practices or records which violate current regulations or guidelines.  Secondly,  that no threats to safety beyond those addressed by the regulations and guidelines, such as emerging pathogens, were found, although diseases prevalent in Mexico and migrating northward, like Dengue, were still under study. (Note: Dengue is of a type of virus which has been proven to be removed during fractionation.) Thirdly, that social concerns we had raised, while of concern, were beyond the agency’s purview – although FDA staff they did indicate that the $325 per month available to each Mexican pheresis donor was not “undue” (although it exceeds what donors could make at most jobs on the other side of the border).

The actual residency requirement for pheresis donors is to be either a) a US Citizen, OR b) have a Social Security card, OR c) have a US immigration card issued by the INS (now USCIS).  Apparently, a Tourist Visa is considered an immigration card, though no migration is under consideration.  In addition, the donor’s address must be within a certain radius from the center, often five or seven miles, to facilitate ease of later recall if needed.  However, that address can be outside of the US.

The abilities of the fractionation process currently to clear more and more pathogens was indicated as a basis for FDA’s willingness to accept product from areas with such environmental risks, poor health status overall, and little access to care.

FDA indicated there are areas of extreme poverty in the US as well. However no exclusionary “redlining” is used to bar persons from certain locations from donating. Such policies would be highly volatile politically, likely impossible to set, and morally unacceptable to many, COTT included.  Similarly, crafting a ‘US residents only’ policy would be difficult; many Canadians and other foreign nationals visiting the US might object.  COTT acknowledged that FDA had forced a discontinuation of collection in other high-risk locations in the past, notably prisons, and to an extent ‘skid row’ areas, however.

Finally, we noted how this issue once again raised the need for the existence of a National Blood Policy, and committed to working with FDA on drafting it.  We are still monitoring the south Texas situation, and may have more to report in coming months.
 
Centers For Disease Control & Prevention (CDC)

The Board of Directors of the Committee is concerned and troubled by the outcome of the recent Health and Wellness for the Hemophilia and Bleeding Disorders Communities Grant Announcement. This program, following years of sole-source grants to the NHF, was this year made a competitive process, with multiple awards. COTT participated in, and supports, this new program. We would like to congratulate the National Hemophilia Foundation and the Hemophilia Federation of America whose proposals were chosen for awards.

Commentary

Our concern is that an entire segment of the hemophilia and the bleeding disorder communities were ignored in this process, those infected with HIV/AIDS, and HCV (Hepatitis C). It is hard for COTT to understand how such a major subset of the community can be ignored by those making funding decisions.

CDC had a golden opportunity to assist in the healing and unifying of our community and chose to ignore this and the needs of a segment of the population, who without the Committee of Ten Thousand would be more and more invisible to the larger hemophilia community and the society. COTT has consistently called for a process of healing and unity building in the entire hemophilia community (see Open Letter below). These calls are clearly being ignored by those in government whose decisions greatly impact our health and wellness.

While COTT has grown up as the hemophilia advocacy organization addressing those infected with HIV/AIDS and HCV, our works, our initiatives, and our vigilance in ensuring the safety and efficacy of the products we depend on, have been in the name of the larger hemophilia and bleeding disorders communities in addition to all those chronic disease communities who depend on the blood supply for their health and wellness. When Ricky Ray was finally passed and funded, the majority of the community and its organizations greatly reduced their governmental activism, specifically both their presence in Congress and more importantly in the regulatory structure that manages the safety of this nation’s blood supply. This has not been true of COTT, which has remained active and vigilant in Congress and in the regulatory oversight, such as FDA and DHHS. Our offices remain on Capital Hill and our presence in the regulatory arena continues to be a daily event. This is not stated as a criticism of other organizations and individuals, it is just the reality of what has occurred. Since its birth in 1989, COTT has been deeply engaged with the federal regulatory system for blood/blood products and drugs. We have always viewed serious engagement with this structure as critical to the current and future health and wellness of our community. As recombinant products have become the standard of care, the perception of risk in the larger hemophilia community has decreased. COTT has always taken the position that we must remain vigilant and participatory in the process regardless of the products we infuse. We have also continued to provide national psychosocial advocacy and support for the HIV and HCV infected segment of our community.

Of the applications that received awards, not a single one addressed the needs and reality of the HIV/AIDS and /or HCV infected segment of our community. What is the message for those living with one or both of these serious and deadly pathogens? Where can we go to seek out appropriate and effective programs and initiatives for our physical and mental health?  How do we address the Post-Traumatic Stress Disorder and associated depression many feel? How do we process the terrible sense of loss that is present in us all? The issue of trauma and Post Traumatic Stress Disorder is relevant to and impacting on the entire hemophilia community. Growing up with hemophilia/bleeding disorders was a major trauma for many in our community. The nightmares of HIV/AIDS and hepatitis C represented an additional, more extreme trauma that left many of the infected totally overwhelmed and unable to cope. Yet we hear that the AIDS/blood epidemic was something historical that is not relevant to the contemporary hemophilia c community. Simply stated, this is an approach rooted in denial. We have never cooperatively worked to process and heal the trauma of the AIDS/blood epidemic. How are the events of the 1980s relevant today? Why do we hear that the survivors and their experiences are not relevant to today’s hemophilia world? We should honor the experiences of all members of this community and undertake mentoring and sharing that is respectful of all our history and what lessons can be learned from that history. We cannot bury our heads to the events of the last 27 years by somehow discrediting or ignoring those that have survived.

 Are we to conclude, as individuals facing one or multiple infections, that government is not concerned or interested in addressing the daily challenges we face? It is difficult not to make this conclusion given the outcome of this CDC competitive process for government funding. From a personal perspective it is troubling and depressing that the needs of this segment of our community are being ignored in the name of “getting beyond the nightmares of the 1980s and 1990s.” It is as if we are invisible to those in the CDC who provide financial support to programs and initiatives in the hemophilia community. The fault line between the infected segment and the hemophilia community-at-large is not the result of those with hemophilia. It is another example of denial and the unwillingness of those in authority, be they government or the medical community, to address the trauma of the HIV/AIDS and/or hepatitis C, HCV, infection of over 90 percent of those with severe hemophilia. In reality the divide was, in large part, the result of this denial to face what occurred and thus refusal to work to heal a community traumatized by the events of the 1980s and 1990s. If we are to move forward in a united and inclusive manner we must address the trauma of the 1980s and 1990s in all sectors of the hemophilia world. Dialogue and cooperative work must be the vehicles for this process to be successful. This critical need has been largely ignored by the hemophilia medical establishment and those in government who provide technical support and the funds necessary to address issues deemed important. Only through transparent, cooperative, work can we truly become a chronic disease community of individuals and families working jointly with our doctors and Hemophilia Treatment Centers to deliver positive medical and psychosocial outcomes for our community.
The urgency of the challenges before us necessitates that we come together, as an entire community of people with hemophilia/bleeding disorders, and work cooperatively to provide proactive and positive solutions that better meet the needs and aspirations of all the people in our community.

> COTT Operations

At its most recent COTT Government Relations Working Group in October, the main topic was the revolutions under way in the private insurance industry. There was concern that, with so many reimbursement problems cropping up, including PBMs, HAGPO, Medicaid, and others, there was a need to mobilize the community – yet in the face of such large institutional changes the dominant mood seems too often to be “So? We can’t change it.”  A decade ago you would never hear that from the hemophilia community, and a year after that, as one fired-up community, we passed the largest relief bill through the US Congress ever.  Our reputation is still remembered on the Hill. We need to become and to stay that mobilized -- the need to fight to keep what we have will not abate any time soon. 

State developments were touched on: Alabama’s recent decision to pay for Medicaid factor users at Medicare rates, which with their furnishing fees and dispensing fees are about the highest Medicaid rates ever attained nationwide.   Alabama also has announced it will adopt the New Jersey Standards of Care principles, developed by the Hemophilia Association of New Jersey, as requirements that its providers must meet, wonderful news. Other states’ ‘carve-out’ programs were mentioned – Michigan, California – with an eye toward possible replication. On the problem front, the main one this time was a rumored threat in Texas to the pricing of factor; stay tuned for more info as it develops.  Keeping an ear out for pending changes was deemed the most important thing right now, and this large standing Work Group is an excellent way to do just that.  More and increasingly frequent calls are being planned; look for reports here.

---=== An Open Letter from the COTT Board of Directors ===---

DOES ANYONE SMELL SMOKE HERE? 
The Hemophilia and Bleeding Disorder Communities have arrived at a crossroads. The structure of health care is rapidly changing or changes are being proposed in the name of better serving those with hemophilia and bleeding disorders. We face consistent and ongoing challenges to our care and the delivery of that care. The emergence of PBMs, Sole-source contracts at the State level limiting or denying choice of product and services, the vertical integration of insurance carriers such as Anthem/Blue Cross/Wellpoint and their entry into the specialty pharmacy business, the rise of the 340b program in hemophilia, conflicts of interest associated with factor sales by the Hemophilia Treatment Centers, the impact of hepatitis C in our community, and finally the stress of having to confront this juggernaut as a person already coping with hemophilia and it’s associated daily challenges.

This rapidly mutating environment is difficult for individuals and families whose care is being altered or threatened in ways that reduce the level of safety and trust for the end users and their families. Simultaneously, many caring health care professionals are attempting to deliver quality care in an environment of decreasing budgets and access to funds to support that care. It is clear that both the community and the medical establishment are frustrated and unsure of the future. We must work to bridge this divide in order to address the concerns of all segments of this landscape. However, we cannot work together if transparency, openness and inclusiveness are not the guiding principles of any process for change.

We possess a unique national health care delivery structure that is critical to the future of comprehensive care delivery for persons with hemophilia and bleeding disorders. We continue to seek full funding from Congress for the nation’s Hemophilia Treatment Centers to protect comprehensive care delivery well into the future. COTT believes we strengthen the HTCs and their programs through full funding, trust building and the addition of community advisory boards where none exists. Some Centers already have established such boards, however, it needs to occur throughout the country as one step in bringing the community and its health care professionals closer together.
             
However, we cannot stand idly by while serious fault-lines go ignored or unaddressed in the hemophilia world. Conflict of interest threatens the very treatment structure we value and left unaddressed can have disastrous consequences as we learned so vividly in the 1980s.

We must, as a community, and from the grass-roots upward, begin a dialogue regarding conflict of interest and its impact in the hemophilia/bleeding disorders world. This dialogue must be inclusive of our entire community. It must begin at the grass-roots within all of our advocacy organizations, local organizations and NHF Chapters as well. In fact, local organizations and some NHF Chapters are in the process of substantively addressing this critical issue. Through understanding what has been accomplished at the grass-roots, each of the three national organizations can come together, in cooperation with existing hemophilia/bleeding disorder health care professionals, to develop conflict of interest free policies consistent with the medical and psychosocial needs of our collective constituency. Those needs must also be met in the context of positive individual and family outcomes for persons with hemophilia/bleeding disorders and their families.         

This process can build broader participation by those who are the end users of the medical and psychosocial services being delivered. The outcome of this process should serve to inform and guide those in government, health care and industry. It also establishes a feedback-loop through community advisory boards, whether at the FDA Center For Biologics, or at the local Hemophilia Treatment Center.  In solving the challenges and threats before us, it is not the time to be less inclusive, while instituting serious changes in the structure of health care delivery in the hemophilia/bleeding disorders world. Transparency, openness and broad community participation must be the guiding principles of any changes or proposals for change. It must not descend into a competition for market share or access to third-party payer contracts, at the expense of individuals and families in our community. We must learn from the nightmares of HIV/AIDS and hepatitis C, not cast doubt on those who have survived, and surviving family members, as somehow to angry to have a rational voice in the future of our community.

We must heal our outstanding wounds and come together with a diverse, inclusive and participatory community, while also healing the relationship between health care professionals and those whose HIV/AIDS and/or hepatitis C has left them with a sense of betrayal and outrage at the events of the late 1970s, 1980s and 1990s. Those health care professionals present during the AIDS/blood epidemic were also traumatized by the loss of so many of their clients and friends. A small close-knit chronic disease community, such as hemophilia, cannot be exposed to this level of trauma without both the people who provide care and the end users of that care being emotionally damaged by the sheer loss of so many community members. We are all damaged from the events of the AIDS/blood epidemic. We must work individually and collectively to process the emotions and move forward in a more unified and mutually supportive climate. It has been interesting to watch as the so-called “old guard”, the HIV/AIDS and hepatitis C survivors of COTT and the NHF, bury their differences, in part, due to our understanding that although we had serious disagreements, we all believed we were acting for the good of the community. For the survivors, this has been an important and healing step in the quest for unity in our community.

The issues of trauma and post-traumatic stress disorder in our community are completely interwoven with the events of the 1970s, 1980s, and 1990s. Hepatitis and the subsequent HIV/AIDS/blood epidemic represent twin traumas overlaid on the initial trauma of growing up with a dangerous catastrophic illness such as hemophilia. HIV, HCV and post-traumatic stress disorder cannot be compartmentalized and taken in a vacuum. They are each part and parcel of a historical continuum of ongoing traumatic stress associated with living with hemophilia, combined with the added shock of the HIV and HCV epidemics. The sense of outrage and betrayal felt by the community was shocking and sobering. The lack of a timely response by our advocacy organizations, the hemophilia medical establishment, and the federal government left us all feeling alienated, isolated and alone. The role of conflict of interest in the hemophilia medical establishment and the impact that had on the AIDS/blood epidemic has never been substantively addressed, and continues to impact the relationship between the HIV/AIDS and/or HCV infected members of our community and the Hemophilia Treatment Centers.

What ultimately is at stake here is the moral and ethical center of the hemophilia community. It is imperative that we again remind ourselves that we are all here in the service of the grass-roots hemophilia/bleeding disorders community. Wherever in the hemophilia world we hang our hats, advocacy, psychosocial, medical, and general support, the health and wellness of persons with hemophilia/bleeding disorders and their families is the reason for our existence.

Respectfully,

The Board of Directors
The Committee of Ten Thousand

Mary-Lou Murphy     Terry McNeill   Ed Maslak    Dick Valdez    Vicky Tody

Larry Allen     Dr. Rich Colvin     Christopher Templin     Diane McClure    
Checole Acuna-Pryor     Corey S. Dubin

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