Vol. 11 No. 1
COTT attended a ‘Health Action 2009’ conference in Washington in late January, at which Rep. Henry Waxman (D-CA), newly Chairman of the House Energy & Commerce Committee (which includes the subcommittee on Health, which he previously chaired), re-asserted his commitment to seeing a health care reform proposal adopted this year, notwithstanding the economic crisis and the large amount of time and attention being devoted to dealing with it, nor the President’s proposals for reform in other areas. Other issues brought to light at the conference can be reviewed in Attachment #1 Report on the Families USA ‘Health Action 2009’ Conference.
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Of course the unexpected withdrawal of the White House candidate for Secretary of Health and Human Services, who was to have also directed the Office on Health Care Reform in the White House, created a major bump in the road to fulfilling that agenda (as has the above-mentioned longer and longer delay, and hardening party-line contentiousness, over the Economic Stimulus proposals).
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> CONGRESS
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In the ripple effect following the rapid development of the first Congressional-White House Economic Stimulus Plan in September and its “implementation,” Congress found representatives of many sectors of the economy beating a path to its door. Mayors and Governors were prominent early on. The main focus of public attention for weeks was then over the bailout of the big three US automakers, which ended up with most of what they asked. There has been general recognition on the Hill and elsewhere that the first major bailout has not worked as desired and indeed appears to have been abused by several of the recipients. There was subsequent to this discovery strong advocacy by many members to go with severe and punitive language in the next round. which a growing minority in Congress are beginning to demand in exasperation. Cooler heads prevailed, and many proposals have been floated on the Hill for components of the next big package.
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As of the New Year, the size estimate of the stimulus package reached $1 Trillion, a number so large that it increases the national debt by 10% in one action, drives planning for rehabilitation of social program budgets after years of decay even further into the ground, and may in fact be too much expenditure for the US economy to even absorb all at once. a bill has passed the House for $850 billion: $550 billion in program expenses is augmented by an expected $300 billion in tax relief. The above questions concerning the magnitude of the measure are still in discussion at the end of January. Two trends have emerged more recently: some contend the measure is too small to have an effect, given the size of the economic problem which by now has grown so much. In addition there are voices calling for tighter controls over the money’s use, going from the hands-off, no-strings approach which last fall’s measure seems to be in hindsight, to controls in legislation as to how the money must be used (and business has proved very adept at finding ways to bank the money instead of beginning to revive commerce), and all the way to nationalization, taking over ownership and direction of any given institution.
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The current economic stimulus bill drafted by the House Democratic majority includes an $80 billion for Medicaid, the same for education, and smaller amounts for unemployment insurance, COBRA costs, law enforcement, military construction and homeland security. The White House has indicated that up to $100 billion will be used for the area that triggered the larger depression gripping the nation: mitigating mortgage foreclosures. Not all could in fact be spent immediately, but may take one or more annual cycles in a given program’s operations. However, the White House defends inclusion of such elements of the bill on the grounds that the recession (or worse) we are in will be with us for more than a few years to come.
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A disturbing part of the Stimulus bill language was proposed, in a section supporting outcomes- or evidence-based medical research, being called ‘comparative effectiveness’ when applied to pharmaceuticals, biologics, and medical devices. The language allowed government bodies such as the National Institutes of Health to convene expert panels to review results of such studies, and in effect endorse the winners – only those most effective – with dire ramifications for others. The problem is that cost is factored into such rankings, and while as we know new products from fractionators increase safety, they may not currently reflect improvements in cost-effectiveness. Moreover, should a panel select one brand of factor over others, there is no built-in assurance as yet that the need for all factor products to be available to all patients would be guaranteed. Alerted to this by the fractionators’ association, PPTA, COTT and others wrote to relevant committee chairs in the Senate to soften this language. Ours is included in this Update as Attachment #2.
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The funding for the operation of all the agencies of the US Government between last October and next September is finally going to be considered and voted on in Congress, but is considered secondary in importance to the passage and enactment of the Economic Stimulus legislation. Though nearly half the size of the proposed Stimulus bill, the $410 billion in funds for operations was put off last fall until this spring in hopes of a more favorable climate – which has come about politically but certainly not economically. Agencies have continued to operate under a ‘Continuing Resolution’ passed at the end of the year, which permits continued operations until March 6th but only at the same level as the previous year, no expansions allowed ... even to address burgeoning needs, like health epidemics, drug safety threats, and the like. The news of imminent action is most welcome, so that such changes can be reflected in increased resource allocations.
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> STATE-LEVEL ISSUES
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Vermont: The Health Department office operating the Medicaid program in Vermont contracted for hemophilia pharmacy effective November 1. Although the regional and national associations were not aware of this plan until less than a week before, HTCs in the state were contacted in advance. The regional association convened a number of input conference calls, and COTT as well as others urged that the MASAC-approved Standards of Service document be shared with that office, and that Vermont be asked to respond whether its terms were met in the contract. The response was detailed and largely indicated compliance, and an action on one item by the contractor so as to come into compliance.
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California: Unlike Congress, which waits until the new year to install newly-elected members, the California legislature waits less than one month after elections: new members were installed December 1, and committee assignments and chairmanships appointed shortly thereafter. These senior players all were present for the 2008 budget fiasco last fall, a three-month deadlock before even a minimum solution could be agreed to. A Special Session already held once last fall to tackle the 2009-2010 budget adjourned without result; a second is planned shortly. The deficit not addressed for ’08 and the already huge and increasing one for ’09 have things near the breaking point. The Genetically Handicapped Persons Program (GHPP) as well as the Medi-Cal (Medicaid) program overall, are likely targets for even greater cuts than the 10% ones threatened and largely delivered last summer. The sides still battle over sources of the savings needed: Republicans, in the minority in the Legislature, refuse to accept any tax increases. A Democratic budget proposed in December was rejected by the minority. At the beginning of January Gov. Schwarzenegger sent a budget for the next fiscal year to the Legislature. The savings proposed
(to close what has come to be a $40 billion deficit) comes from $15 billion in new revenues (raising sales, oil extractors, and property taxes); $10 billion in loans; and $16.5 billion in spending cuts, including $5 billion from base K-12 school funding and $3 billion from mandatory furloughs for state employees and from eliminating any state add-ons for the aged, blind, disabled and recent immigrants in the Supplemental Security Income program. In January, over objections from the state Comptroller (but lost in Court) the Governor began mandatory unpaid two days per month furloughs for state employees. One Lake Tahoe ski resort is offering discounts to state employees on friday February 6, the first furlough day.
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New York: The state Medicaid office has announced contracts for hemophilia pharmacy – multiple contracts, so concern about the sole sourcing actions in other states is not present, however the process exempts 340b HTCs (Hemophilia Treatment Centers which sell factor). Thus, those currently using one of the state’s centers can continue there; those in more rural areas must however subscribe to one or the other of the state’s new contractors, regardless of whatever more hemophilia-focused pharmacies they have been using.
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> AGENCIES
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The Advisory Committee on Blood Safety and Availability met in December. The main and only topic of discussion was “The Responsibility of Blood and Plasma Centers to Donor and Public Health.” In COTT testimony we pointed out that conspicuously omitted from these concerns was recipient health. This testimony is included in this Update as Attachment #3. Although the issue (of recipient health) was not ignored in the presentations given at the meeting, the clear focus was on donors, perhaps because the blood banking community has no direct contact with recipients but can track and work to improve care provided to, and health of, their donors. This refers by and large to their health after, and between donations, not before – in other words not about the inadequacies of donor screening. But stories increasingly abound of donor applicants becoming overloaded with the huge number of questions now asked, and, either on the entire document or beginning at some point in it, simply answering all remaining questions regarding risk factors the same way – negative for any risks. This definitely compromises recipient health greatly, despite new highly accurate levels of testing.
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COTT President Corey Dubin, testifying on behalf of COTT, stated that, “we need to reenergize the efforts of the Advisory Committee to set the national blood agenda, especially in the context of the incoming Obama Administration.” Dubin challenged the committee to, “move forward on the establishment of a mandatory adverse events reporting system.” The current system, the FDA’s Adverse Events Reporting System (AERS/MedWatch), is largely voluntary, only requiring reporting of medication-related fatalities.
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Much of the agenda was devoted to current regulations about donor suitability (screening), and reporting of adverse events, including data from a study showing how low the rate of such events was. (The data from this study would not have been available from AERS.) The current presence of emerging conditions like Dengue and Dengue Hemorrhagic Fever, Chagas, and Babesiosis, to name a few, would be far easier to track if reports of them came in routinely. At present FDA receives almost no reports through its AERS system of less-than-fatal adverse events, as they are not required; FDA staff reveal few reports of any kind come in to AERS on a voluntary basis.
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Also in December COTT board and staff met at the FDA with members of the Office of Blood Research and Review and it’s director, Dr. Jay Epstein. Topics included follow-on biologics (production controls already in place in Europe would be worth consideration here), collection in south Texas (again, general environmental conditions cannot be taken into consideration in screening of individual donors) , and reporting systems used by FDA (new systems like Sentinel that searches other federal health databases will be in place soon to improve adverse event reporting). Dr. Epstein included in the meeting some twelve additional members of his staff and related offices in the agency; the meeting ran considerably over its scheduled ending time. COTT was thus extremely grateful for this latest example of its ongoing close working relationships with FDA. Baltimore City Health Commissioner Dr. Joshua Sharfstein is a finalist to head FDA.
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Our regular feature of excerpts from recent FDA Enforcement Reports can be found at the end of this Update as Attachment #4. A number of drugs are included this time to give biologics users some sense of the scope of some of the actions FDA takes … and how much more of it gets past inspectors. Case in point: the un-inspected plant found to have been shipping salmonella-laced foods to schools nationwide under USDA contract. During the period in question FDA was making 40% fewer food plant inspections than in the same period before, due to steady cuts in food safety funds as part of overall reductions in FDA resources at a time of increasing need.
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> INDUSTRY
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The Plasma Protein Therapeutics Association (PPTA) held a dinner for stakeholders – manufacturers (their members) and consumers – in conjunction with the December meeting of the Advisory Committee on Blood Safety and Availability, discussed above. Presenters reviewed some of the trends expected to be of high priority in the new Congress, excluding health care reform: comparative effectiveness, and follow-on biologics.
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This year’s PPTA World Conference, set for March in Paris, features a session on “The Precautionary Principle and its Influence on the Manufacture and Access of Plasma Protein Therapies.” The HIV contamination of the US blood supply in the early 1980s marked the end of an era in which environmental management and infection control decisions were made solely on the basis of evidence, usually in the form of published studies. The lack of studies kept the industry from immediately changing its manufacturing to include viral inactivation steps, already tested and available, when reports of HV infection started coming in. The Precautionary Principle was developed only after that time, after so many died in our community. The Principle stands as an alternative to solely evidence-based research as a basis for action. In its shortest form, the Principle reflects the first line of the Hippocratic Oath taken by all new Doctors of Medicine: “First, do no harm.” In practice this means that if there is even anecdotal evidence that a product is causing widespread infection, such as by passing along to recipients a virus inadvertently allowed into the blood supply, then protective changes should be made at once despite the absence of studies, if society would benefit. It has driven the addition of many safety tests to blood products manufacture since that time, and the flyer on the session notes that the costs of such measures, among other things, have increasingly pitted the Principle against “the other main paradigm of the modern policy world – that of evidence-based measures.” This could suggest a weakening of the stature of the Precautionary Principle, a slide back toward a solely-evidence-based rationale for even beneficial changes. Remember, every suit brought by families against blood centers for the HIV contamination was defeated by the contention that ‘we were operating under the rules and requirements of manufacture in effect at that time.’ But, it happened. Infections move a lot faster than the publishing of studies does.
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Wellpoint has continued to expand the number of states in which its for-profit subsidiary payors (Blue Cross) require clients with hemophilia to use either an HTC or its own mail-order pharmacy in Indiana; the total now stands at 10 of their 14 states. Wellpoint was in the news in January, twice. In the first story, it was suspended by the federal government from adding new members to its Medicare Advantage program on the grounds of “undisclosed compliance problems,” so the impact is difficult to see, but clearly not good news for the company. The second, only one day later, was more specific: Wellpoint was banned from selling or even marketing Medicare health or drug plans, after thousands of its over-65 clients were dropped from its rolls, for prescription drug coverage or completely, due Wellpoint said to computer problems. The government letter stated however that Wellpoint had a “longstanding and persistent failure to comply with [Medicare] requirements” that was beginning to pose “a serious threat to the health and safety” of these enrollees. Although the period of time during which these clients were without care is not known, it caused many to go without (rather than pay full price for) prescriptions for cardiac, pulmonary, neurological and other serious conditions. Wellpoint says it is working to reinstate these clients.
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> COALITIONS
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After informal conversations at and between various meetings, the national hemophilia groups as well as other disease community representatives also using blood products, held a first-time-in-years “Plasma Users Coalition (PUC) meeting. COTT convened this group in the year 2000, in order to facilitate coordination of policy statements as needed and in general forge a larger like-minded network than each group had alone. The structure of the group atrophied over time, however collaboration on specific projects has increased greatly of late. However, this year’s meeting, after introductions by NHF, focused solely on one issue: Lifetime Caps.
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> COTT Operations
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COTT President Corey Dubin, Board Member Chris Templin, and staff John Rider and Dave Cavenaugh traveled to the Boston area during December for a series of meetings. One was with the New England Hemophilia Association Board Member Kate Muir and staff Steve May; the other was a COTT planning meeting, attended by the above-mentioned COTT representatives and also Co-Vice Presidents Terry MacNeill, Mary Lou Murphy, and Board Member Richard Colvin, MD, all Boston area residents. Major agenda items included progress in planning the construction of an AIDS/Hemophilia memorial, and planning for the celebration of COTT’s 20th Anniversary this summer with an event in Washington.
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COTT is considering acknowledging this history in all of its products this year with the following:
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“Twenty-six years of AIDS and 20 years of COTT, the Committee of Ten Thousand: Out of the ashes of the devastation of 10,000 lives emerged a grassroots advocacy group that has brought the hemophilia community a federal advisory committee now in its 12th year, a $600 million relief bill, and plans for a national blood policy, maximizing blood safety well into the 21st century.”
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BLOOD SAFETY SUMMARY
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Selections from recent and current FDA Enforcement Reports are included in this Update as Attachment #4. Some items of interest have been emphasized (boldface, italics).
COTT acknowledges the assistance of Hemophilia Health Services and Factor Support Network
in publication of this issue of the COTT Washington Update.
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Attachment #1: Report on the Families USA
‘Health Action 2009’ Conference
The annual Health Action conference put on by Families USA, a Washington-based advocacy group, has for years drawn key speakers from the Hill and the Administration to provide a briefing on and illuminate next steps in the development of key health and social policies. This year of course was special, with the kickoff of the Obama Administration, its commitment to health care reform, and the major complication of the crisis in the economy.
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Held January 29-30 in Washington, the conference drew some 300 participants from around the nation, largely in advocacy work themselves. COTT was pleased to hear ‘chronic disease’ mentioned in the six major addresses given at the conference, but only one or two times. Further, although we encountered representatives of other high-cost chronic diseases there (Gaucher’s, MPS) no actual caucus of them, or of all chronic diseases, was held. More work is needed.
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We mention hearing ‘chronic disease’ as a term in discussions of health reform planning, because with such small acknowledgement of even that relatively widely-known term, we would find NO mention of hemophilia per se. More work is needed on that, too.
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In general, few attendees came from disease/disorder community-based organizations, except as described below. Represented were state officials, university faculty, church groups, seniors groups, health rights / health law groups, foundations, legal aid, many American Cancer Society chapter representatives, public schools, food banks, and many Medicaid advocacy groups.
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Following are brief summaries of remarks of some of the key speakers:
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Sen. Chuck Grassley (R-IA), Ranking Member, Senate Finance Committee
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Sen. Baucus’ (Chair of Senate Finance) White Paper issued last fall presents a balanced approach in that it specifically incorporates some of our systems needed the most but thought of the least, like Veterans Hospitals and the Indian Health Service.
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Many of the under- and uninsured are eligible for assistance programs but don’t participate, whether from lack of knowledge or choice.
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Long term care should be a part of any plan; in place now it can be aided through tax credits. A goal should be to let people stay in their homes as long as they can.
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The next FDA Commissioner should be drawn from outside the FDA, and outside the pharmaceutical industry. A culture has developed in the agency favoring new drug release as a priority greater that the guarantee of patient safety.
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Rep. Steny Hoyer (D-MD), House Majority Leader
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We must pursue health reform, and this year. Bad economic conditions do not mean we can’t be bold.
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Sen. Debbie Stabenow (D-MI), Senate Finance Committee
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The component in the Economic Stimulus bill for subsidizing COBRA payments for the newly unemployed could be thought of as a way of tiding people over until we get to the “big change people have been hoping for.” (health reform)(COBRA permits those laid off from jobs and job-related health insurance to continue to be covered, by the same insurer, for 18 months after severance. However, the policy is an individual policy, less broad and far more costly than the previously-held group policy.)
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Uwe Reinhardt, Princeton University
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The first factor in the recent destruction of the US economy was the maxing out of credit cards. In a country in which the top 1% of the population controls 34% of the economy, we must acknowledge we don’t have a middle class we have an aristocracy. Bankers’ behavior before the collapse, and since, reminds me of Marie Antoinette: so distanced from the world around them they say “let them eat cake” when hunger news comes. Alan Greenspan accelerated that warped momentum – he was the Head of Infectious Diseases for the financial world. These people think it’s normal when, after you take $400 billion from the government, you go out and buy a $50 million jet. Although the popular wisdom is that the private sector works better than government, we now have the data to resoundingly say it isn’t true. Accordingly, nationalization may be the answer.
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Henry Waxman (D-CA), Chairman of the House Energy & Commerce Committee
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In 1993, many policymakers favored some version of sweeping reform, generally without consensus though. Such plans were their first choice. The trouble was, they had no second choice. Nothing jelled, nothing passed, Now, we say the Obama plan is our first choice, but if it doesn’t work out, we have clear options for less-sweeping number two choices.
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Now we have a chance to accomplish what we’ve always wanted. Every American ought to have health insurance. This is an exciting time. Our new President has put affordable, accessible health care front and center, and with the leadership of all of the key committees also committed to this goal, this is the time, this is the year, and this is why we can pass health insurance legislation this year.
Health care is the true third rail in American politics. We don’t need Harry & Louise, we need Thelma & Louise.
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E.J. Dionne, Syndicated Columnist
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William Cohen (R-ME) said ‘The government is the enemy until you need a friend.‘ The late Sen. Fritz Hollings spoke of a man who returned from World War II and got a college degree under the GI Bill, buys a house with an FHA loan, puts his son through college on a Federal loan, and sees his parents into their retirement thanks to Social Security and Medicare – and then votes Republican because he wants to get government off his back.
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In times of stress we refer to government social programs not as a burden but as a form of insurance, to which we are entitled.
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The job facing us now is one of meshing systems. As Peter Orszag of the Obama White House puts it, we cannot hope to achieve comprehensive coverage without controlling costs – but we cannot hope to achieve cost containment without attaining universal coverage. We must be explicitly committed to both, and make the combination come about.
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Our response to the health crisis in this country will be comprised of two components, one rapid, because speed matters, & one comprehensive, because the crisis raises larger issues. Like the relation between public and private, that between the market & the government, and that between the common good vs. individual initiative. In each case both have value. A democracy permits lively debates, a prerequisite for consensus, only after which can true support for change occur.
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Atul Gawande, Clinton White House, Obama White House
As the telephone network in this country grew, it needed to be modernized repeatedly. But, to use a much more contemporary term, it could not simply be ‘re-booted.’ There is no reset button. It had to keep functioning during any major renovations. As a result it looks like a piece of living coral, growing some on this side, some on that side; unlike coral it has patches all over it. My point is, a health care system cannot be re-booted either. It’s far worse than the telephone system, with hundreds of patches, thousands of codes. We must build on what’s there now. The health system is also like a damaged ship, mercenaries on board, 10-15 innocents thrown overboard a day to keep it afloat.
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Master planning is seductive but dangerous. Chairman Mao’s ‘Great Leap Forward,’ a sweeping agricultural reform in China in the 50’s and 60’s, ended up killing 30 million people from famine. Medicare Part D, launched just a few years ago, threw millions of the infirm elderly out of their existing medical arrangements, denying even lifesaving drugs like insulin from people for weeks. It terminated 60,000 pharmacies, and caused 37 out of 50 states to declare a medical emergency and seek (other) Federal assistance. No doubt Part D killed many people.
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David Blumenthal, Massachusetts General Hopital (Co-designer of Obama Health Plan with David Cutler, Harvard)
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His book due out this spring on health reform actions of past presidents makes it clear: to a President, the issue of health is irrevocably personal. His views to some extent are molded by the care he’s received in his life. Pres. Eisenhower’s mother-in-law died in the White House; her illness deeply upset Ike. Two of President Nixon’s brothers died young of tuberculosis. In political terms, though, too, health care is the acid test of an Administration’s domestic policy.
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Do not forget that in previous administrations, specifically under Johnson in 1964, major health legislation could pass only because there was a since-unheard of 2/3 Democratic majority in both the House and the Senate. When Roosevelt enacted Social Security in 1935, that support was also there.
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[The medical/insurance community’s Harry and Louise commercials in 1993 quashed the Clinton plan. Do you not suppose even more vocal and pervasive protests were heard against Medicare in 1964? They cried ‘socialized medicine’ over the SCHIP expansion attempt last year, while it was merely extending something to the children most in need. They had cried ‘socialized medicine’ in 1993 and it also worked. They no doubt cried it in 1949 when Truman brought the matter up but lacked the votes, and in 1935 around Social Security. But they were needed. Rural conservative farmers in the breadbasket states saw Social Security as saving their lives, which otherwise stood a very good chance of being drastically shortened by poverty and hunger. Too, don’t forget that Social Security was one of several responses to the Great Depression of 1929; maybe the second-greatest crash of 2007 could trigger new care programs too …]
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Paul Begala, CNN (Clinton White House)
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How not to pass health care: Nixon’s health insurance proposal was 70 pages long, Clinton’s was 1,350. He was too much of a wonk. The Clinton White House closed-door Health Care Task Force of 500 people failed to bring in the Hill Committee Chairs whose support it would need! So when it got to them, it was DOA.
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The first Senator to campaign in his state, riven by economic downturn, on a platform that health care system change would be key to economic improvement, won re-election handily.
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Other than party numbers needed on the Hill, the key to passage of health care reform is money. Not money for commercials. The whole battle: do the advocates have money for more lobbyists than the opponents will have. In 1993-4 the advocates had $15 million for this, the opponents spent $100 million.
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Now it’s different, but with a twist: Obama just spent $600 million to get elected, so the scale is different – but the average donation was $86. That means he has millions of Americans invested in seeing his plans work! And he doesn’t ‘have a list of’ 15 million supporters, he sits at the center of an active, communicating network of 15 million supporters. He’s Internet-savvy, as proven by his weekly Saturday addresses airing on YouTube.
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.Attachment #2: COTT letter on
Comparative Effectiveness
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Committee of Ten Thousand
Advocates for Persons with HCV-HIV/AIDS
236 Massachusetts Ave., NE Suite 609 · Washington, DC 20002
(202) 543-0988 · (202) 543-6720 fax · www.cott1.org ·
cott-dc@earthlink.net.
January 26, 2009
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The Honorable Michael Enzi
United States Senate
Washington, DC 20510
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Dear Senator Enzi:
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The Committee of Ten Thousand is an organization within the hemophilia community, representing particularly those infected with HIV and/or Hepatitis C through their FDA-licensed medications in the 1980s.
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We write today over a concern relevant to all in the hemophilia community. We are increasingly in battles with insurers and state Medicaid Directors who, seeing the high per-patient cost of treatments for hemophilia, decide they can engineer cost savings by limiting patient choice at the pharmacy.
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There are several kinds of hemophilia, although most are in one category, Factor VIII (8). Moreover, there are older-formula medications, derived from human plasma, and newer, synthetic ones. People in our community have learned that they need access to all factor products, for two reasons. First, one company’s product may work better than another’s for a given individual, for a variety of reasons. Second, from time to time the medications cease to be effective – bleeding continues – so switching to a specific product, known as Factor VII (7), and administering it in copious quantities for a time despite its much higher cost, is necessary.
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Certain statin drugs work better for some individuals than others do. A range of antibiotics is available for selection based on patient characteristics. These examples of the need for choice from the pharmaceutical side pale in the face of the lifesaving importance of the high-cost medications necessary in chronic disease, especially in high-cost chronic orphan diseases.
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Please excise language in the stimulus bill report language which leaves the important review of comparative effectiveness in the hands of those with no proven knowledge of the impact of the limitation of choice on the patients so affected. Oversight bodies must be created only with explicit attention to these qualifications, not left only to those swayed by cost considerations alone.
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Thank you.
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Sincerely.
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Dave Cavenaugh
Government Relations
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Attachment #3: COTT Testimony at ACBSA
Advisory Committee on Blood Safety and Availability
December 2008
“The Responsibility of Blood and Plasma Centers to Donor and Public Health”
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Thank you Mr. Chairman for this opportunity to comment on the question posed by the theme for this meeting. As you may imagine, our views on the subject are strongest in an area omitted from your statement of this theme – the health of the recipients of the blood and blood products being collected.
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While much attention and expense has been allocated to ever-increasing testing of these products to assure their safety, and computerization and automation of materials handling systems put in place as well, the weekly FDA Enforcement Reports demonstrate clearly that errors persist.
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The West Nile Virus story is perhaps the best example of rapid and effective response. Funded to develop a test and then a mechanism for screening under an IND, the private sector within one year from startup had in place in highest-incidence areas effective screening test devices, providing addition of a new level of protection without disruption of the collection process.
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Because of the plethora of vectors for this virus, the testing (and interceptions which, though low level, help point to new areas of high incidence) is helpful in public health efforts far beyond blood collection.
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Within our field, the emergence over the last decade of new and threatening blood-borne and other-transmissible viruses and agents has, interestingly enough, not made a dent in the general public perception of the safety of the US blood supply. NAT testing, close FDA monitoring (and raising the rigor of) cGMP practices, and a continuing reduction in the number of sources of potential contamination have all helped maintain this view; it has not been easy but the results are clear.
We still worry about permutations of Avian Flu, and no one has really ever seen a prion, and MRSA seemingly came from nowhere and now plagues hospitals nationwide. By “we” here I mean the public, since these are by and large outside the blood community’s concerns. However, recent statements about the erosion of the public health infrastructure in America, invisibly to most, combine with these concerns to make us all just a little more suspicious of the safety of any health care process; this may in the future tend to erode public confidence in blood safety. This would be unfortunate, since it would almost certainly exact a sharp decrease in donors, fueled initially by the AIDS-era misperception that donating is itself risky. But this time, this initial reason for declining donor pools would be augmented by more general malaise and discontent with health care safety and treatment, and the decline would continue for some time.
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Returning to the subject of donor health in plasma pheresis, we would just allude to stories we are receiving as the national/global economic crisis enters its fourth month of the breakdown of the free trade zone along the Mexican-US border, and ask both FDA and plasma collectors for an update on the types and health status of donors they are using there.
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Attachment #4:
Recent FDA Enforcement Report excerpts
November 26, 2008
[Drugs]
PRODUCT
1) Oxycodone and Acetaminophen Capsules, USP, CII, 5 mg/500 mg, Rx only, 100 count bottles; NDC # 52152-041-02, Recall # D-055-2009;
2) Chlorzoxazone Tablets, USP, 250 mg, Rx only, 100 count bottles, NDC # 52152-053-02, Recall # D-056-2009;
3) Ursodiol Capsules, USP, 300 mg, Rx only, NDC 52152-060-02 - 100 count bottles NDC 52152-060-03 - 250 count bottles, Recall # D-057-2009;
4) Naltrexone Hydrochloride Tablets, USP, 50 mg, Rx only, NDC 52152-105-30 - 30 count NDC 521520105-02 - 100 count bottles, Recall # D-058-2009;
5) Carisoprodol Tablets, USP, 350 mg, Rx only, NDC 52152-136-02 - 100 count NDC 52152-136-05 - 1000 count bottles, Recall # D-059-2009;
6) Meperidine Hydrochloride Tablets, USP, CII, 50 mg, Rx only, 100 count bottles, NDC 52152-158-02, Recall # D-060-2009;
7) Meperidine Hydrochloride Tablets, USP, CII, 100 mg, Rx only, 100 count bottles, NDC 52152-157-02, Recall # D-061-2009;
8) Betaxolol Tablets USP, 10 mg, Rx only, 100 count bottles; Also labeled as Kerlone (Be tazolol Hydrochloride) Sanofi-Synthelabo/Sanofi Aventis, NDC 52152-179-02 - Amide NDC 0024-2301-10 – Sanofi, Recall # D-062-2009;
9) Betaxolol Tablets USP, 20 mg, Rx only, 100 count bottles; Also labeled as Kerlone (Betaxolol Hydrochloride) Sanofi-Synthelabo/Sanofi Aventis NDC 52152-1180-02 - Amide NDC 0024-2300-20 – Sanofi, Recall # D-063-2009;
10) Trimethobenzamide Hydrochloride Capsules, USP, 300 mg, 100 count bottles, Rx only, NDC 52152-185-02, Recall # D-064-2009;
11) Loxapine Capsules, USP, 5 mg, Rx only, NDC 52152-191-02 - 100 count NDC 52152-191-05 - 1000 count, Recall # D-065-2009;
12) Loxapine Capsules, USP, 10 mg, Rx only, NDC 52152-192-02 - 100 count bottles NDC 52152-192-05 - 1000 count bottles, Recall # D-066-2009;
13) Loxapine Capsules, USP, 25 mg, Rx only, NDC 52152-193-02 - 100 count bottles NDC 52152-193-05 - 1000 Count bottles, Recall # D-067-2009;
14) Loxapine Capsules, USP, 50 mg, Rx only, NDC 52152-194-02 - 100 count bottles NDC 52152-194-05 - 1000 count bottles, Recall # D-068-2009;
15) Pentazocine HCL and Acetaminophen Tablets 25 mg (base) and 650 mg, CIV, Rx only, 100 count bottles, Also labeled as Talacen CIV pentazocine hydrochloride and acetaminophen. NDC 52152-213-02 - Actavis/Amide NDC 0024-1937-04 - Sanofi-Aventis, Recall # D-069-2009;
14) Oxycodone Hydrochloride Tablets, USP, CII, 15 mg, NDC 52152-214-02 -100 count bottle NDC 52152-214-11 - 10 x 10 blister packs, Recall # D-070-2009;
15) Oxycodone Hydrochloride Tablets, USP, 30 mg, CII, Rx only, NDC 52152-215-02 - 100 count bottles NDC 52152-215-11 - 10 x 10 blister pack, Recall # D-071-2009;
16) Rifampin Capsules, USP, 300 mg, Rx only, 30 count bottles, NDC 52152-217-30, Recall # D-072-2009;
17) Buspirone Hydrochloride Tablets, USP, 5 mg, Rx only, 100 and 500 count bottles, NDC 52152-222-02 - Actavis/Amide 100 count NDC 52152-222-04 - Actavos/Amide 500 count NDC 0904-5587-60 - Major 100 count NDC 0904-5587-60 - 500 count, Recall # D-073-2009;
18) Buspirone Hydrochloride Tablets, USP, 10 mg, Rx only, 100 and 500 count bottles, NDC 52152-223-02 - Actavis/Amide 100 count NDC 52152-223-04 - Actavis/Amide 500 count NDC 0904-5588-60 - Major - 100 count, Recall # D-074-2009;
19) Buspirone Hydrochloride Tablets, USP, 15 mg, Rx only, 100, 180 and 250 count bottles, Also labeled for Major Pharmaceuticals, 100 and 180 count bottles. NDC 52152-224-02 - Actavis/Amide 100 count NDC 52152-224-22 - Actavis/Amide 180 count NDC 52152-224-03 - Actavis/Amide 250 count NDC 0904-5589-60 - Major - 100 count NDC 0904-5589-93 - Major - 180 count, Recall # D-075-2009;
20) BusPIRone Hydrochloride Tablets, USP, 30 mg, Rx only, 60 and 180 Tablets, NDC 52152-280-01- 60 count; NDC 52152-280-22 - 180 count, Recall # D-076-2009;
21) Tizanidine Hydrochloride Tablets, 2 mg, Rx only, 150 and 500 count bottles, NDC 52152-236-21 - 150 count NDC 52152-236-04, Recall # D-077-2009;
22) Tizanidine Hydrochloride Tablets, 4 mg, Rx only, NDC 52152-234-21 - 150 count, NDC 52152-234-04 - 500 count, Recall # D-078-2009;
23) Mirtazapine Tablets, 15 mg, Rx only, NDC 52152-226-30 - 30 count bottles, NDC 52152-226-04 - 500 count bottles, Recall # D-079-2009;
24) Mirtazapine Tablets, 30 mg, Rx only, 30 and 500 count bottles, NDC 52152-227-30 Amide/Actavis 30 count NDC52152-227-30 Actavis - 500 count NDC 02274361 - Cobalt Recall # D-080-2009;
25) Mirtazapine Tablets, 45 mg, Rx only, 30 and 500 count bottles, NDC 52152-228-30 - 30 count NDC 52152-228-04 - 500 count, Recall # D-081-2009;
26) Quinaretic (Quinapril Hydrochloride and Hydrochlorothiazide) Tablets, 10 mg/12.5 mg, Rx only, 30 and 90 count bottles, NDC 52152-238-30 - 30 count NDC 52152-238-08 - 90 count, Recall # D-082-2009;
27) Quinaretic (Quinapril Hydrochloride and Hydrochlorothiazide Tablets) 20mg/12.5mg, Rx only, 30 and 90 count bottles, NDC 52152-239-30 - 30 count bottles NDC 52152-239-08 - 90 count bottles, Recall # D-083-2009;
28) Quinaretic (Quinapril Hydrochloride and Hydrochlorothiazide Tablets) 20mg/25 mg, Rx only, 30 and 90 count bottles, NDC 52152-240-30 - 30 count NDC 52152-240-08 - 90 count, Recall # D-084-2009;
29) Quinapril Tablets, USP, 5 mg, Rx only, 90 count bottles, NDC 49884-992-09, Recall # D-085-2009;
30) Quinapril Tablets, USP, 10 mg, Rx only, 90 count bottles, NDC 49884-993-09, Recall # D-086-2009;
31) Cilostazol Tablets, 100 mg, 60 tablets, Rx only, NDC 52152-250-01, Recall # D-087-2009;
32) Hydromorphone HCL CII Tablets, USP, 8 mg, Rx only, 100 Tablets, NDC 52152-260-02, Recall # D-088-2009;
33) Isradipine Capsules, USP, 2.5 mg, Rx only, 60 Capsules, NDC 52152-263-01, Recall # D-089-2009;
34) Isradipine Capsules, USP, 5 mg, Rx only, NDC 52152-264-01, Recall # D-090-2009;
35) Dipyridamole Tablets, USP, 25 mg, Rx only, Film coated tablets, 100 and 1000 count bottles, NDC 52152-265-02 - 100 count NDC 52152-265-05 - 1000 count, Recall # D-091-2009;
36) Dipyridamole Tablets USP, 50 mg, Rx only, Film coated tablets, 100 and 1000 count bottles, NDC 52152-266-02 100 count NDC 52152-266-05 1000 count, Recall # D-092-2009;
37) Dipyridamole Tablets, USP, 75 mg, Rx only, Film coated tablets, 100 and 1000 count bottles, NDC 52152-267-02 100 count NDC 52152-267-05 1000 count bottles, Recall # D-093-2009;
38) Meloxicam Tablets, 7.5 mg, Rx only, 100 and 500 count bottles, NDC 52152-285-02 100 count NDC 52152-285-04 500 count, Recall # D-094-2009;
39) Meloxicam Tablets, 15 mg, Rx only, 100 and 500 count bottles NDC 52152-286-02 100 count NDC 52152-186-04 500 count, Recall # D-095-2009;
40) Trimipramine Maleate Capsules, 25 mg, Rx only, 30 and 90 count bottles, NDC 52152-293-30 - 30 count, NDC 52152-293-08 - 90 count, Recall # D-096-2009;
41) Trimipramine Maleate Capsules, 50 mg, Rx only, 30 and 90 count bottles, NDC 52152-294-30 - 30 count NDC 52152-294-08 - 90 count, Recall # D-097-2009;
42) Trimipramine Maleate Capsules, 100 mg, Rx only, 30 count bottles, NDC 52152-295-30, Recall # D-098-2009;
43) Cyclobenzaprine HCL Tablets, USP, 5 mg, Rx only, Flm coated tablets, 100 count bottles, NDC 52152-301-02; NDC 50111-820-01, Recall # D-099-2009;
44) Cyclobenzaprine HCL Tablets, 10 mg, Rx only , Film coated tablets, 100 and 1000 count bottles, NDC 52152-302-02 - 100 count NDC 52152-302-05 - 1000 count, Recall # D-100-2009;
45) Hydroxyzine HCL Tablets, USP, 10 mg, Rx only; 100 and 1000 count bottles, NDC 52152-311-02 100 count NDC 52152-311-05 1000 count, Recall # D-101-2009;
46) Hydroxyzine HCl Tablets, USP, 25 mg, Rx only, 100 and 1000 count bottles, NDC 52152-312-02 100 count NDC 52152-312-05 1000 count, Recall # D-102-2009;
47) Hydroxyzine HCL Tablets, USP, 50 mg, Rx only, 100 and 1000 count bottles, NDS 52152-313-02 100 count NDC 52152-313-05 1000 count, Recall # D-103-2009;
48) Phendimetrazine Tartrate Tablets, USP, 35 mg, CIII, 1000 tablets;
NDC 52152-327-05, Recall # D-104-2009
CODE
1) All lots within expiry;
2) Lot: 70006A, Exp. Jan 09;
3) thru 48) All lots within expiry;
RECALLING FIRM/MANUFACTURER
Actavis Totowa LLC, Totowa, NJ, by letters on July 18, 2008. Firm initiated recall is ongoing.
REASON
cGMP Deviations
VOLUME OF PRODUCT IN COMMERCE
Too numerous to count
DISTRIBUTION
Nationwide
.
.
[Biologics]
.___________________________________
PRODUCT
Source Plasma, Recall # B-0259-09
CODE
Units: 379071389, 379066273, 379065960, 379065356, 379065039, 379063383, 379063053, 379062966, 379062661, 379062030, 379061711, 379061183, 379060773, 379059391, 379059091, 379041993, 379038404, 379038351, I59019792, I59019123, I59018851, I59018439, I59015559, I59015309, I59014124, I59013914, I59012464, I59011959, I59011719, I59010930, I59000701
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources Inc., Lafayette, LA, by fax on February 25, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had been previously deferred for testing reactive for Hepatitis C (HCV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
31 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma, Recall # B-0270-09
CODE
Units: TQ019781, TQ019601, TQ019060, TQ018811, TQ018326, TQ018075, TQ017834, TQ014813, TQ014706, TQ014472, TQ014374, TQ014145, TQ014010, TQ013804, TQ013680, TQ013486, TQ013375, TQ013166, TQ012322, TQ011373, TQ010813, TQ010418, TQ010338
RECALLING FIRM/MANUFACTURER
IBBI dba Knoxville Plasma Corp., Knoxville, TN, by telephone and facsimile on April 17, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was permanently deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
23 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma, Recall # B-0271-09
CODE
Units: TQ022741; TQ022388; TQ021472; TQ021244; TQ020363; TQ020180; TQ019704
RECALLING FIRM/MANUFACTURER
IBBI dba Knoxville Plasma Corp., Knoxville, TN, by facsimile on March 26, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
NC
.
January 14, 2009
.
PRODUCT
a) Fresh Frozen Plasma, Recall # B-0362-09;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-0363-09;
c) Platelets Leukocytes Reduced, Recall # B-0364-09
CODE
a) Units: 019GR58259, 019GR58261;
b) Units: 019GR58244, 019GR58247, 019GR58248, 019GR58249, 019GR58250, 019GR58251, 019GR58252, 019GR58253, 019GR58254, 019GR58257, 019GR58261;
c) Units: 019GR58244, 019GR58248, 019GR58249, 019GR58251, 019GR58252, 019GR58253, 019GR58261, 019GR58263
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by facsimile on June 7, 2007. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units
DISTRIBUTION
TN, KY
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0371-09
CODE
Unit: 123769835
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on July 8, 2007.
Manufacturer: Blood Systems, Inc., Albuquerque, NM. Firm initiated recall is complete.
REASON
Blood product, which was possibly contaminated with Propionibacterium species, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NM
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall @ B-0383-09
CODE
Unit: 019FZ35332 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by telephone on March 7, 2007 and by letter dated March 9, 2007. Firm initiated recall is complete.
REASON
Blood products, collected using apheresis kits that had exceeded the acceptable time period for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0392-09
CODE
Units: 5425275, Part A and B
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by telephone on January 27, 2007 and by follow-up letter on January 31, 2007. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Peptostreptococcus Asaccharrolyticusi, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0334-09
CODE
Unit: W050908009749
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Bethlehem, PA, by telephone on July 8, 2008. Firm initiated recall is complete.
REASON
Blood product, labeled as negative for red cell antibodies, but collected from a donor with a history of testing positive for red cell antibodies, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
February 4
___________________________________
PRODUCT
a) Recovered Plasma, Recall # B-0403-09;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0404-09
CODE
a) and b) Units: 9204591
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Lake Charles, LA, by fax on October 1, 2008 and by electronic mail on December 20, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX, Switzerland
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0405-09
CODE
Unit: 72F681998
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by fax on June 9, 2008. Firm initiated recall is complete.
REASON
Blood product, leukoreduced after the post collection time limit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0452-09
CODE
Units: W051708200353 Part 1; W051708200353 Part 2; W051708200533 Part 1; W051708200533 Part 2; W051708200533 Part 3; W051708200704
RECALLING FIRM/MANUFACTURER
Rhode Island Blood Center, Providence, RI, by facsimile on July 11, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the medication Finasteride, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
RI, PA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0450-09
CODE
Unit: 2139137
RECALLING FIRM/MANUFACTURER
Central Jersey Blood Center, Shrewsbury, NJ, by telephone on February 12, 2008. Firm initiated recall is complete.
REASON
Blood product, which was possibly contaminated with gram positive Actinomycetes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0453-09
CODE
Unit: 6641593
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter on May 2, 2008 and September 17, 2008. Firm initiated recall is complete.
REASON
Blood product, which may have been exposed to unacceptable temperatures during storage, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0454-09
CODE
Units: 6226592; 6226593; 6226594; 1625143
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by telephone on July 10, 2008. Firm initiated recall is complete.
REASON
Blood products, which were labeled with an incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NJ
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