Nov-Dec 2007 Vol. 9 No. 7
- China
In 1986 fear of contaminated blood from countries with mad cow disease led the Chinese government to ban all imports of clotting factor concentrates. Gradually recognized, in-country scandals over HIV contamination at blood banks through infected donors and equipment, such as through use on several persons without being cleaned, became a source of shame worldwide. Now, however, the efforts to improve practices has had the effect of cutting the available supply of safe blood so much that factor output is down 40%. The hemophilia community’s organization in China, Hemophilia Home, has circulated a desperate request for letters of support from hemophilia communities around the world to the Chinese government, asking it to drop the ban on imported factor (which by and large has, since 1986 when the Chinese banned it, been clean), so that supplies of clean product can be available once again to all needing it. Without the ban, a serious shortage will continue and worsen; deaths have occurred. All three national US groups are responding.
-Canada
Please see the new Errata listing at the end of this Update for corrections to the story in the last issue concerning the acquittal in Canada of those knowingly selling contaminated factor in the past.
> CONGRESS
Congress finally went home, at the middle of the week before Christmas, after an increasingly tumultuous year – one that saw mentioned several times in the last month the threat of a federal government shutdown as happened for a few days ten years ago. The logjams broke, but without exception in favor of the minority party. With narrow majorities in both chambers, razor-thin in the Senate, and a President who gave not an inch in his demands for budget cuts in domestic programs and full funding for a war without end or a clear enemy.
The President used a stealth weapon to achieve his goals – social program funding under his maximum, and no new programs within it: the veto. Until this fall, in six years of his administration he did not exercise his veto authority once. In the last four months, he has used it six times. Republican lawmakers have seen this show of teeth, and been encouraged to be even less conciliatory to the other side than they were before.
The SCHIP (Medicaid State Childrens Insurance Program) after two vetoes itself, was finally sent to the White House merely as a continuation of current program levels, a far cry from what the majority, and a broad cross-section of the country, wanted: a doubling of the program. Thus, not only are potential enrollees locked out, the nation is sent a message that the current administration does not support health care for all. There is no other way to read a result that denies coverage to five million children, on top of the six million in the program currently.
Appropriations bills for the operation of the government from last October 1 until next September 30 met somewhat the same fate. Although the President signed the first appropriations bill to cross his desk, the Defense Department, both SCHIP and the next appropriations bill – funding the Departments of Labor, Health & Human Services, and Education - were vetoed, and the majority Democrats in the House were unable to muster the 2/3 vote necessary to override the vetoes – by very close margins. Democrats were extremely exasperated by the President’s rigidity on the health funding bill, since his grounds for veto were that the bill exceeded his spending targets announced last February … by some two percent. They noted that the war in Iraq is so costly currently that it consumes an amount greater that that 2% in a matter of days.
In the end, all 11 remaining appropriations bills, including the re-crafted Labor appropriation, were rolled into one massive Omnibus Bill, compliant with the President’s target levels. All Democratic efforts to tie military funding to an Iraq withdrawal timetable failed. One junior Democratic Senator noted that he expected intransigence to give way to compromise, and was surprised when the minority party closed ranks. The President has listed problems with each of the 11 bills in question, not all of which may have been resolved; a veto of the entire appropriation, while unlikely, is not out of the question.
Many in Congress on both sides of the aisle feel that next year, Mr. Bush’s final year in office, will see similar dynamics. Senator Max Baucus (D-MT), Chair of the powerful Senate Finance Committee, which crafted a Medicare bill only to have its provisions beaten down under veto threat to an almost unrecognizably small scope, however, said “Getting closer to the election, I think more members of Congress are going to be listening more closely to their constituents than they are to the White House, assuming the White House takes the same rigid ‘Dr. No’ stance.” At any rate, the lame duck period of Congress next fall – after elections but before the winners take office – will hardly be a time for the (likely much fewer) members of the minority to stand rigid.
The Disability Medigap proposal, HR 1282, ends the year as it began – with only about 1/10 of House member co-sponsoring it in that chamber, and no Senate sponsor as yet, despite four or more waves of visits and expressions of interest but more to co-sponsor than to sponsor. The break over the holidays is only between the 2007 first “session” and the 2008 second “session” of the current 110th “Congress,” so efforts on this bill can pick up again in the new year without need for re-introduction of the measure.
> AGENCIES
COTT staff and board members met with the Division of Blood Disorders (DBD) and the Director of Blood Safety of CDC at their offices in Atlanta, Georgia the week following the NHF Meeting in Orlando. The CDC meeting covered projects funded this year, at least one project not funded (COTT’s), planning for outreach to the HIV and HCV infected hemophilia community (including those suffering Post Traumatic Stress Syndrome, at whom our proposal was primarily directed), expanded scope of DBD (as outlined in Orlando) to include sickle cell anemia among other conditions, and a review of latest CDC concerns about pathogen transmission via organ and tissue transplants, including the need to learn and monitor a new and much more emergency-driven area of sharing of biologics among people.
At the Leadership Meeting held in advance of the NHF’s 59th Annual Meeting in Orlando at the beginning of November, many HTC program Regional Directors and Regional Coordinators were in attendance. This provided COTT an opportunity to hear their views on various current topics, including but not limited to those on the agenda. Circumstances did not permit any lengthy, open exchange on the subject of the 340b program or uses to which its revenue from factor sales were currently being put.
The Regional officers of the program, as appointed by HRSA, the non-CDC office that provides base funding for the HTCs, represent the true decision-making authority of the program in many ways. It is important for those involved with advocacy for the hemophilia community to be aware of that fact. For example, at least five Regional Coordinators and one Regional Director sit on the 16-member board of the new corporation set up to house the hemophilia database, ATHN.
> INDUSTRY
The item drawing the largest proportion of staff time and resources at COTT in the last two months has been the announcement by Wellpoint, the corporation which has purchased Blue Cross programs in 13 states and converted them from non-profits to for-profits, that, state by state, Blue Cross members with hemophilia will only be able to procure their factor through Blue Cross’ own pharmacy, Precision Rx. The states and timing of this change are as follows:
September 1 2007: California
January 1 2008 Wisconsin, Ohio, Indiana, Kentucky
February 15 2008 Missouri
Later in 2008 Maine, New Hampshire, Connecticut, New York,
Virginia, and Georgia.
COTT has expanded several of its recent Government Relations Working Group conference calls recently, inviting board and staff members from both NHF and HFA, and representatives of the January-February targeted states onto these calls. Several of them had already been approached by this pharmacy, Precision Rx; during these meeting the companies were informed of the interest in the matter of the national hemophilia organizations. Having then seen our materials on the matter on the COTT website, www.cott1.org, they proposed to ‘allay’ our concerns in one phone call. COTT had that conference call with Precision Rx on December 6th; results were inconclusive. We certainly were not impressed by their defense of ‘everybody’s doing it’ in using a company they own to act as the sole pharmacy whose bills they would pay. Everybody’s NOT doing it, it is very close to monopoly. In addition, COTT has informed select Congressional officecs of this situation; Inquiries are being made.
COTT is concerned about the larger issues and implications of Anthem/Wellpoint/Blue Cross. This began in California and is also slated to be implemented in eight additional states in January of 2008. Anthem/Blue Cross of California informed its hemophilia/bleeding disorder clients that they would be required to obtain their clotting factor concentrates from Precision Rx, a specialty pharmacy owned by the Anthem/Wellpoint/Blue Cross conglomerate. Essentially a vertically integrated third party payer is entering the health care delivery market for hemophilia / bleeding disorders. This will provide this company with the ability to control the market price to the end user, as well as the amount reimbursed by the third party payer (Anthem/Blue Cross) thereby giving them an inordinate amount of influence over the marketplace for persons with hemophilia/bleeding disorders.
While Anthem/Blue Cross crunches the numbers and sees dollar signs, we see human beings and families having their health care security and safety exploded in the name of profits for Anthem/Blue Cross shareholders. In the healthcare marketplace, there are those providing excellent service and care and those who fail to meet good standards. The ones delivering positive client/family outcomes should be rewarded, not run over by a Wal-Mart style approach to service delivery in health care.
Our community is not to be expendable in the support of profits and market share. We have lived through the nightmare of the AIDS/blood epidemic, which devastated our community. We do not intend to be the economic guinea pigs for Anthem’s bottom line profits. The hemophilia community served as this nation’s early warning system for the blood supply. Over 90 percent of those with severe hemophilia were infected with HIV/AIDS and/or hepatitis C.
For Blue Cross of California HMO policyholders this change is mandatory, as Blue cross has closed its network to all other homecare and specialty pharmacy providers in the clotting factor marketplace. If you have purchased a PPO policy with out of network benefits, you will be required to pay the out of pocket maximum if you chose to continue with your existing provider or any other provider, as Anthem Blue Cross is not contracting with other providers to add even more pressure for a policy holder to use its specialty pharmacy, Precision Rx. Anthem/Wellpoint/Blue Cross has agreed to allow the 340b Hemophilia Treatment Centers to participate at this time. However, comments made by company officials raise questions regarding how long into the future the HTCs will be allowed to participate in the mix.
We are already hearing very negative reports from Anthem/Blue Cross clients and families who have already been forced to transfer their home infusion services to Precision Rx. In one instance, a prescription for HIV/AIDS medications was not filled for three weeks. The client was consistently told that Precision Rx had not received the prescription. The doctor had, in fact, sent the prescription. Three weeks passed; the client was finally told that Precision Rx could not fill the prescription. This is a serious example: the potential impact of the client being off anti-viral medication for this length of time is the development of resistance to the medication. Is this the improved service Anthem/Blue Cross alleges they intend to deliver?
FDA -- Border Flap
COTT continues to monitor the alleged abuses of blood collection centers in South Texas. Shortly after this matter broke, additional stories from elsewhere in the country about high-risk donors routinely using plasma pheresis centers to get money for drugs purchased even before leaving the center emerged, as did a case of a warning letter to a pheresis center in the midwest that listed pages and pages of violations from a recent inspection. These, and the lesson that the three cases in concert pose for the community, are discussed further below, after a review of the Texas situation.
President Jan Bult of PPTA, the fractionators’ association, traveled to South Texas to inspect the centers there firsthand. He gave his report at a special meeting of PPTA “Stakeholders” – industry and consumer groups alike – on November 16 on the Texas issue. His report concluded the meeting; COTT’s overview of its concerns started it. Other consumer groups spoke to the issue, then all were treated to several briefings on PPTA operations, unrelated to the case at hand but by implication pertaining to it. Bult’s presentation gave a report of smiling donors, happy to provide for others, feeling no exploitation (Bult himself had to explain to them what that meant). COTT felt the report lacked much in the way of realism, glossing the tone by touching on high points only with no grounding in history, recruitment, viral marker results over time, and the like.
COTT’s presentation ended with our desired outcomes of the policy discussion:
> Plasma collection ceases within 50 miles of US/Mexican border
> PPTA and it's members review each US collection site's donor pool,
to determine whether economic stress is present which can lead to higher viral risk and/or lower accuracy in donor screening information. Where
such stress is found, collection ceases.
> FDA revises plasma donor geographic eligibility criteria to limit donors to those with US addresses
> Work begins on a broad framework for blood policy
COTT is continuing to work on specific issues relating to health disparities across the US/Mexican border in Texas, seeking health and demographic information from national organizations. The recent report by the American Association of Blood Banks (AABB) indicating the presence of Chagas disease in the United States blood supply provides strong motivation to continue this inquiry.
Two other cases of problems at pheresis collection centers came to light this fall as well. One depicted a center in Kansas City located in a high-drug-use area, with the concluding comment that all persons in the waiting room were addicts. The third case is based on an FDA Warning Letter issued to a center in Ohio, listing several pages of violations in donor screening, care of product once obtained, and so forth. Together these cases are a reminder to COTT and hopefully to all of the need for vigilance from the consumer side, not just the FDA, to safeguard the collection of blood and plasma destined for infusion in our own arms.
COTT has worked with NHF and HFA to craft a Joint Open Letter on Safety (attached at the end of this Update), directed to industry and regulators alike, concerning these recent findings. It lays down several requests for more timely communication by both sides with the hemophilia community when such events are occurring, and even when they are not, to keep us informed. A weekly “Enforcement Report” on FDA visits to blood establishments is available on FDA’s website at www.fda.gov/opacom/7alerts.html . Two of the reports from December are also presented at COTT’s website (SEE NEXT DOCUMENT).
ATHN (American Hemostasis and Thrombosis Network)
As COTT was finalizing its comments on ATHN’s answers to a set of questions we publicly posed to them last spring, we were invited to the first meeting of its Community Liaison Committee in late November. The one-day meeting began with talks on several areas of operations at the organization; in the early afternoon organizations invited – NIH and CDC as well as NHF, HFA and COTT – were asked to take 10 minutes each to enumerate their hopes and expectations for ATHN. COTT’s remarks differed sharply from most others. We identified three main areas of not hope but concern: 1) That the entire enterprise was invented in secret, at least from the hemophilia community, and what this portends for the future; 2) That this joint venture between the HTCs and Novo Nordisk, to put it in a nutshell, proposes to obtain the data it would compile into so valuable a database via strong-arm tactics on HTC clients, by condoning current practices which limit free choice among HTC-using community members; and third, that these data, obtained free of charge, will be sold to industry: at this meeting this was made explicit, in slide presentations, that this was in the works. Up until now questions about sale of the data have been answered inconclusively. For example when asked if their major funder Novo Nordisk would be getting some of the data, the reply was that they would not receive “preferential” access, though the term was left undefined.
> COTT Operations
COTT Town Meetings
COTT has resumed its cycle of Town Meetings with a large gathering at NHF, and is laying plans for many more in the coming year. Watch this space for announcements.
Government Relations Working Group
Hearing more and more about the Anthem takeover of home care pharmacy arrangements for those under Blue Cross (see article above) the November 15th call was devoted to this upheaval. Anthem plans to use its own Precision Rx pharmacy, canceling home care contracts in five states for Blue Cross members effective January 1 – Wisconsin, Ohio, Indiana, California and Kentucky -- and in Missouri on 2/15. California was to have begun September 1 but due to difficulties parts of the plan were pushed back to January 1.
Due to the community-wide nature of the threat and the need for a collective response, COTT is using this already-planned call series for the purpose. The calls have been expanded to include NHF and HFA, as well as representatives from the target states, among others. Because of the urgent and threatening nature of the crisis (and the long holiday period impeding action), calls have been accelerated to bi-weekly. Materials have been developed, some of which are on the COTT website.
The enormity of the battle facing us was realized at several points during the November 15th call. The urgent need for outcomes-based clinical findings showing existing methods of care work best was stressed.
The target states have been urged to set up meetings immediately with their state Attorney General, the Insurance Commissioner, and members of the state legislature, particularly the Health Committee Chair. In addition, they were encouraged to mount media campaigns with major newspapers in the state, TV/Radio, and through other like-minded organizations. The national organizations will help, but Chapters and their members, however, will do the bulk of the work, contacting and talking with key reporters, writing Op Ed pieces for the main in-state newspapers, and scheduling the state government visits.
BLOOD SAFETY SUMMARY
International: In Japan a court decided settlement amounts in an HCV contamination suit should be decided by the parties involved. In China, hemophiliacs plead for government to lift its ban on imported factor as domestic supplies have been cut so drastically in the cleanup of widespread contamination in collections. Industry: Three cases of problems at pheresis collection sites came to light this fall. Safety concerns at the Texas site were minimized by PPTA at a special seminar on the subject; issues concerning a second site found to be in a high drug use area remain to be studied; and issues raised by a multi-page listing of violations in an FDA Warning Letter concerning a third site are being studied. Vigilance is a priority.
Errata: In the September-October Update article on the Canadian court decision, two notes:
1) John Plater’s correct organizational affiliation in this context is former Vice President of the Canadian Hemophilia Society. 2) James Kreppner’s remarks are his alone, not as a representative of either the Society or of Canadian Blood Services.
COTT acknowledges the assistance of Hemophilia Health Services and Factor Support Network in publication of this issue of the COTT Washington Update.
Committee of Ten Thousand 236 Massachusetts Ave., NE Suite 609 Washington, DC 20002
800-488-2688 * 202-543-6720 fax
cott-dc@earthlink.net
Attachment: Joint Letter on Blood Product Safety
An Open Letter to the Manufacturers of Clotting Factor Products and the Government Agencies who Regulate Them:
Individuals affected by bleeding disorders depend on the availability of safe and efficacious clotting factor concentrates for their very lives. In the 1980s, the community was ravaged by the proliferation of HIV/AIDS and HCV tainted plasma derivatives. Many lessons were learned during that period about the importance of vigilance, and today we are fortunate to have an adequate supply of safe products, both recombinant and plasma-derived. However, recent events have created the perception that vigilance has started to wane.
The record of progress in addressing safety issues in recent years must not result in reduced vigilance as known and unknown pathogens continue to pose threats to the end users of clotting fuctor concentrates and our nation's blood supply. The need for vigilance never diminishes.
In the spirit of ongoing vigilance we are writing to express substantial community concern regarding recent issues that have potential implications for the safety of plasma derived clotting factor concentrates. Fortunately, the issues in question, which include but are not limited to cross-border plasma collection and regulatory violations at one collection center outlined in an FDA warning letter, did not result in tainted product or any other immediate danger to consumers. Nevertheless, there is genuine concern that these matters may not have initially been taken as seriously as they should have been. Furthermore, consumer organizations first learned of these issues from the media or other second-hand reports. We are appreciative of the recent efforts to provide us with answers to questions and other information addressing our concerns. However, our concerns do not end there, nor should efforts to address them.
As organizations representing consumers with heightened sensitivities and, more importantly, critical vulnerability, we need a higher level of communication on an ongoing basis. In particular, we request the following:
1. When an issue comes to light that may have implications for product safety on any level, we want to know about it - and by that we mean that we want direct, proactive communication.
2. Communication should include an explanation of the problem itself, an analysis of its potential impact on product safety and patient health, and a description of the steps that are being taken to rectify it if necessary.
3. Historically, issues of blood and blood product safety have been addressed on a site by site and/or event by event piecemeal basis. Although much progress has been made, what is ultimately needed is a national blood policy as exists in other countries. A national blood policy would provide an expanded regulatory framework within which many of the questions and issues we are identifying could be addressed in a more comprehensive and timely manner.
By working together to improve our vigilance and our communications around blood and product safety issues, we can all help ensure that safe, effective treatments will remain available for all who need them.
Sincerely,
Corey S. Dubin President, COTT
Carl Weixler President, HFA
Raymond W. Stanhope Chair of the Board, NHF
Mark W. Skinner President, WFH
