September 14, 2006

This Week in Washington
1. NORA Bi-Monthly Meeting
2. DC CARE Consortium Hosts Preventive HIV Vaccine Forum

Ryan White CARE Act in Brief

This Week in Washington
1. NORA Bi-Monthly Meeting
On Monday, September 11, 2006 National Organizations Responding to AIDS (NORA) held its bi-monthly meeting at the American Public Health Institute in Washington D.C. The meeting included updates of the Fiscal Year (FY) 2007 Budget and the Ryan White CARE Act Reauthorization, given by Donna Crews, Director of Government Affairs AIDS Action. Donna’s Updates were accompanied by a discussion of microbicide and vaccine developments both in legislation and scientific research. Speakers included Anna Forbes, Deputy Director of The Global Campaign for Microbicides, and Peg Willingham, Senior Director of Public Sector Development and the International AIDS Vaccine Initiative (IAVI) and NORA Executive Committee member.

Peg Willingham presented first. As she began her presentation entitled, “The Road to an AIDS Vaccine,” she stressed the importance of pairing treatment and prevention together as we fight the AIDS epidemic. She went on to explain that vaccines are an essential part of prevention. They are non-controversial prevention pieces in comparison to other methods. She said, “While finding a vaccine that is 100% effective, covers every transmission route, and would be easily accessible is ideal, it is a very difficult challenge. But is finding an HIV vaccine possible? Yes.”

Ms. Willingham pointed out that Merck is currently the only pharmaceutical company actually investing shareholders’ dollars into research of an HIV vaccine. They are looking at a cell mediated vaccine, one which hopes to trigger the immune system to fight off infection. She said that Merck expects to release the data from this trial in 2008. IAVI and several other governments are continuing to research cell mediated vaccines as well as a traditional antibody vaccine.

She feels that after the International AIDS Conference, political commitment to prevention and vaccine research is high. It is the hope of IAVI that the conference may stimulate more capital interest and investment into vaccine research. Currently the vast majority of investments in vaccines have come from the public sector, with little commercial support.

She stated that funding is the critical issue. The nature and science of the HIV disease makes vaccine research extremely costly. She affirmed that there are currently 30 clinical vaccine trials taking place throughout the world, and only one has made it through Phase 3. While the vaccine did not prove effective, Ms. Willingham believes the trial itself proved to be a success. It showed that a clinical Phase 3 trial can take place in the developing world. She said, “IAVI has shown that these complicated scientific trials can take place in Africa and can have a skilled work force with world class facilities.” For more information on the work that IAVI does please visit www.iavi.org.

Anna Forbes spoke next on Microbicides. She commented on how fitting it was to pair a conversation about microbicides and vaccines at the same NORA meeting. She believes they are two similar topics with new awareness and enthusiasm in the wake of Toronto.

Ms. Forbes first shared some statistics. In Sub-Sahara Africa 77% of the 9 million HIV positive youth (ages 15-25) are women. In the United States 56% of all adolescent HIV infections reported are among girls. AIDS is the leading cause of death in African American women ages 24-34. She said, “In light of these statistics, women are in dire need of a prevention method they can control.”

Ms. Forbes then gave an overview of products in the microbicide pipeline. There are currently 5 products in Phase 3 trials expecting to release their clinical data by 2008. The most promising is Carigard®, which may be available by 2010, but most likely not in the United States due to its 50-60% efficacy. Most of these first line products may have a contraceptive effect. There are currently 9 products in Phase 1 trials and 10-20 still being studied in the lab. The second and third generation microbicides in Phase 1 and 2 are products from anti-retrovirals which have the potential to have increased efficacy and decreased contraceptive capabilities.

Ms. Forbes said that most of the funding for these trials is coming from small bio-technology companies, non-profits, and academic institutions. Big pharmaceutical companies have not invested in microbicides, and there is a serious lack of public funding for this research. She explained that microbicide trials are actually cheaper than the drug development process of many other medications; however they are far more difficult to conduct. She explained that because microbicide trials are prevention trials, they must prove a negative while enrolling very large numbers to do so. As of 2005, $140 million had been invested in microbicide research. She said, “An additional $106 million is needed for microbicide research to be adequately funded.”

The Global Campaign for Microbicides promotes microbicide advocacy across organizations, demands the resources from Congress to make microbicides a reality, and encourages an increase in private investment for microbicide research. The Global Campaign for Microbicides is pushing passage of the Microbicide Development Act which could give increased money to NIH for microbicide research and require NIH to form a Microbicide Development branch to streamline the development research. This Act has been introduced in the last 6 Congresses without passage, but is gaining support each time. Please visit www.global-campaign.org/legislativeadvocacy.htm to find information you can use to urge your legislator to support the Microbicide Development Act.

Lastly, Ms. Forbes spoke on the potential public health impact of microbicides. She shared the data analysis that if a microbicide that is only 60% effective was offered to 73 low income countries and used by 20% of the people in that country reached by the health care system during only 50% of their unprotected sexual acts, 2.5 million HIV infections could be averted over the next three years. This proves the enormous HIV prevention gap in the developing world.

2. DC CARE Consortium Hosts Preventive HIV Vaccine Forum
On Thursday, September 14, 2006, DC CARE Consortium and the Vaccine Research Center sponsored an informational lunch event as part of the AIDS Clinical Trial Information & Orientation Network (ACTION) Speaker Series on HIV Prevention Vaccine Research. David Mariner, the coordinator of ACTION, started the session by explaining the goals of ACTION and the Speaker Series. ACTION exists to provide information and resources to those interested in HIV/AIDS clinical trials, and to support an active community voice in HIV/AIDS research. The Speaker Series serves this goal by bringing those who work on vaccine trials and the National Institutes of Health (NIH) and the community together once a month for a luncheon discussion.

Both Diane Johnson, Recruitment Specialist for National Institute of Allergy & Infectious Disease (NIAID), and Laura Novik, Clinical Trials Core Nurse of NIAID, presented a general overview of HIV Prevention Vaccine research and trials taking place at the National Institutes for Health. They explained the complex problems in creating an effective preventative vaccine for HIV and the importance of increased participation in vaccine trials.

Laura Novik explained that HIV is a constantly mutating virus. Its outer proteins change quickly and are easily hidden. Attempts to create a vaccine that would enhance our antibody response to the virus are increasingly difficult. Antibodies often have a hard time recognizing the virus, which does its early damages to T cells, the exact cells in our immune system that would fight it. An effective vaccine must acknowledge that these T cells may be damaged and must be able to work against a disease that has the ability to recombine. There is not one human case that has completely overcome HIV and rid their body of the virus, unlike many other viruses such as hepatitis and measles. Therefore, there is no model of an effective immune response to HIV for a vaccine to emulate. Ms. Novik stressed that despite these challenges, the development of a vaccine is critical to overcoming this epidemic. She said, “We must continue to support vaccine research and be patient with its progress.”

Ms. Johnson spoke about the participation process for the trials currently taking place at NIH. She explained the ethics that govern these trials and the safety precautions for participants. Currently all NIH trials are in Phase I safety trials and are in dire need of more volunteer participants. She said that variables such as race and gender could impact how vaccines affect a population. She stressed the necessity in having a wide diversity of races and ethnicities enrolled in the trials, particularly calling upon the African American community.

If you would like to learn more about vaccine research being conducted at NIH or may be interested in participating in a vaccine trial with the Vaccine Research Center, please visit www.vrc.nih.gov.

Ryan White CARE ACT in Brief
In a fast moving series of events following the return of Congress from the August recess, the pace of the Ryan White CARE Act reauthorization has picked up considerably. On Thursday, Sept 7, 2006 the members of the bi-partisan/bi-cameral Ryan White Care Act Reauthorization committee released a House draft version of the bill. Swiftly following, the staff members hosted two “stakeholders’ meetings” to discuss concerns about the latest draft. The first meeting was held on Monday, September 11, 2006. In response to very strongly raised concerns at the September 11th meeting, a second meeting was held on Friday, September 15th.

At the September 11th meeting, a coalition comprised of AIDS Action Council, AIDS Alliance for Children, Youth and Families, Communities Advocating Emergency AIDS Relief (CAEAR) Coalition, National Association of State and Territorial AIDS Directors (NASTAD), National Association of People with AIDS (NAPWA), National Minority AIDS Council (NMAC), Project Inform, and the Southern AIDS Coalition released a joint statement detailing strong concerns about six elements of the bill, including changes to hold harmless provisions, funding concerns, formula data concerns, issues regarding “EMA, transitional area and emerging community” eligibility, a proposed early diagnosis grant program, and support for Title II consortia. Frank Oldham, Executive Director of NAPWA and a person living with HIV, read the letter. Members of each of these coalitions and allies (over half the room) stood up as the letter was read. The text of this statement is below.

The reading of the statement produced an extremely emotional moment for both the committee (which had hoped that their work was nearing completion) and the audience. In reaction the committee stated disappointment that these issues had not been worked out earlier, but to their credit pledged to try to accept the community statement and work to make changes. The community meeting then proceeded through a number of questions and answers attempting to work and discuss the issues.

Perhaps, the most powerful series of questions occurred near the end of the meeting when Project Inform staffer Ryan Clary noted that a number of Title I Eligible Metropolitan Areas (EMAs) which had a very high prevalence rate for people living with AIDS, would be removed from Title I since the committee’s bill called for the elimination of a grandfather clause that had allowed these EMAs to retain eligibility. Mr. Clary’s question was quickly followed up by a number of statements from people living with AIDS in these communities who stated that they would not be counted under the new rules. Committee staff said that they would review the issue.

During the meeting, Connie Garner, a staff member for Senator Kennedy (D-MA) ranking member of Health, Education, Labor and Pensions (HELP) committee which has jurisdiction over the bill, told the members of the coalition that if this meant that they were opposing the bill, she required a letter stating that the members were in opposition for her boss. In response the community coalition members submitted a letter on September 12th stating, “We do not support the bill as released on September 7th in its current form.” The letter is below.

On Thursday, September 14th, the community coalition released a second document to the committee calling for specific changes to the Ryan White reauthorization legislation. That statement is also below. The committee hosted a second stakeholders meeting today to discuss potential changes to the bill.

At today’s meeting, the committee staff announced that they were making several changes to the bill. In particular, the committee announced that they had accepted several changes as proposed by the community. Those changes included the creation of a back end prevalence test keeping communities that do not meet Title I EMA incidence criteria EMAs if they have a prevalence of 3000 or more living AIDS cases for “Tier I,” 1500 or more cases for Tier 2 and in 750 or more cases for Emerging Communities which is contained in Title II.

The committee also announced that although they could not change Hold Harmless to be longer than three years, they would use the tightest language possible to ensure that supplemental funds would continue to go to a “restoration’ fund designed to make up the loss prior to being used for “demonstrated need.”

The committee also responded to concerns that states which use code based systems would not be ready to shift to a name based system in Fiscal Year 2011. They said that since learning more about states’ de-duplication efforts they felt comfortable allowing states making the shift to use the names in their name based system that had previously been de-duplicated, even if the state’s name based system was still considered immature by the Centers for Disease Control and Prevention. The community is continuing to work with the bipartisan, bicameral committee to address further proposed changes as much as possible before a markup.

In both the September 11th and September 15th meetings the committee stressed that they were on a very tight deadline. The committee seeks to have the bill passed by Congress and signed by the President by September 30, 2006 to be effective before the beginning of Fiscal Year 2007 on October 1, 2006. During the September 13th meeting, committee staffers stated that if the bill is reauthorized after October 1, 2006, it will not go into effect until Fiscal Year 2008. If this occurs, appropriations will be made under the existing formula allocations from the 2000 reauthorization, including switching to HIV names.

The expected process for passage is that the House and Energy and Commerce committee plan to mark up the Ryan White Care Act on Wednesday September 20th. The CARE Act will be part of a larger markup that includes National Institutes of Health reauthorization and other bills. The Senate will then replace S.2823 with the Energy and Commerce Committee’s marked up version of the bill through a manager’s amendment. It will then be passed on the Senate Floor using unanimous consent (perhaps as early as the end of the week). Once it passes in the Senate, the identical bill will go to the House Floor under suspension of the rules requiring a two thirds majority vote, perhaps as early as September 25th. Once the bill passes in the House, The President then must sign the bill before it becomes law.

AIDS Action and the community coalition continue to work towards reauthorizing an acceptable bill via the bipartisan, bicameral process.

Text of the Community Coalition Statement, September 11, 2006:

Joint Statement Endorsed By:
AIDS Action Council
AIDS Alliance for Children, Youth and Families
Communities Advocating Emergency AIDS Relief Coalition
National Alliance of State and Territorial AIDS Directors
National Association of People with AIDS
National Minority AIDS Council
Project Inform
Southern AIDS Coalition

We thank the Members and staff of the Senate Health, Education, Labor and Pensions Committee and the House Energy and Commerce Committee for working together, in what we acknowledge has been a long and arduous process. On behalf of people like me living with HIV/AIDS who depend on this lifesaving program, we thank you for your leadership on this issue.

I am speaking on behalf of an ad-hoc coalition of national and regional HIV/AIDS organizations that represent and serve as our constituency, people living with HIV/AIDS, state AIDS directors, AIDS service organizations, and minority community-based organizations who collectively are committed to ensuring that care, treatment, and services meet the needs of people living with HIV disease across the U.S.

We believe that the House draft of the Ryan White CARE Act Modernization bill has addressed some important concerns raised by our individual organizations. However, as a coalition, we strongly believe that there are critical improvements in both funding formulas and policy components that must be made prior to passage of this legislation.

Over the past several months, the HIV/AIDS community in general, and our organizations in particular, have been distanced from and dissatisfied with the process. The process for input has largely consisted of meetings such as this one, in which we are left to quickly respond to a proposal that has already been completed before a planned markup. The CARE Act is a lifeline for hundreds of thousands of people with HIV around the country. As such, the complex nature of the legislation and reauthorization of this law requires significant input and inclusion of the community at this critical juncture to ensure that all persons living with HIV/AIDS, regardless of their geographical location, are appropriately served.

We want to work with Senators Enzi and Kennedy and Representatives Barton and Dingell, along with committee Members and staff, to craft changes to the draft bill that was released on Thursday. Beyond today's session and prior to the mark-up, we request a meeting with the four respective Members at which we would work together with the committees of jurisdiction to forge the compromises necessary to ensure reauthorization of the RWCA before the end of this month.

We believe that with our active participation, compromises to the current bill can be made and reauthorization can be completed. There are still several key issues that must be addressed and we must work together to resolve them. We have outlined our major concerns - Hold Harmless; Funding Issues; Title I Tier 2 Eligibility; Title II Consortia Support; the Early Diagnosis Grant Program; and Data Concerns - and some recommendations for addressing them in an attached document. We understand that the current version of the bill has been painstakingly crafted, and that many compromises have been made. We are nevertheless obligated to point out those issues which must still be addressed.

Our coalition stands together behind the principle that all those infected with HIV in this nation should have access to care and treatment and to the important support services that ensure they can meet the demands of the rigorous medical protocols required to manage this ravaging disease. We do not believe that there must be winners and losers in this reauthorization process in order to address the needs of people living with HIV/AIDS in all parts of this country. The final bill must address the needs of communities where the rates of new HIV infection are growing rapidly without undermining the care structures in those communities where the majority of those living with HIV reside.

On August 2, the bipartisan, bicameral committee and Administration representatives made a presentation to the National Governors’ Association. At that time, representatives of the committee stated that they would welcome compromise proposals that had broad support from the HIV/AIDS community. In good faith and as a response to the committee's statement, our organizations came together and have been developing a document that includes important concepts and issues that we believe form the basis of such a compromise. We were encouraged to release this document to House and Senate committee members on Wednesday, September 6th. We did so knowing that there were problems with the Title I portion of the document, particularly for code-based states, which we were working to resolve, but believing that Members wanted the compromise issues identified.

In particular, our data runs highlight an issue long raised by our groups as an area of concern. Without funding estimates for Title I supplemental awards, data runs do not accurately reflect the impact of the bill. We recognize the limitation of the committee's ability to do this, but believe that accurate data runs, including the supplemental, are the only way to anticipate unintended consequences and ensure the Members of the committee have a complete picture of the impact of the legislation.

On behalf of this individual living with HIV/AIDS and the many thousands of my brothers and sisters with HIV disease and AIDS, thank you for your time today. Our organizations look forward to our meeting with you in which our coalition partners and committee leadership can negotiate improvements to the proposed bill to ensure its viability and passage as soon as possible.

Letter from the Community Coalition, September 12, 2006:

September 12, 2006

To: The Honorable Michael Enzi, Edward Kennedy, Joe Barton, and John Dingell
United States Congress, Washington, DC

Karl Zinsmeister, Assistant to the President on Domestic Policy
The White House

Cc: Senate HELP Committee, House Energy and Commerce Committee
Yuval Levin (White House), Marty McGeein (HHS)

Re: Community Letter on Ryan White Reauthorization

The undersigned national, community-based AIDS organizations would like to meet with you, your staff, and other principles charged with writing legislation to reauthorize the Ryan White CARE Act. We do not support the bill as released on September 7th in its current form, and would like to work out compromises and finalize legislation with strong community support by September 30th.

Enclosed is a statement endorsed by all of us that outlines our concerns on funding and policy components that must be addressed before we can support the bill. We look forward to meeting with you and other authors at any time convenient for you.

Please do not hesitate to contact any of us if you have any questions.

Thank you, as always, for your tireless leadership on behalf of people with HIV/AIDS.

Sincerely,

AIDS Action
AIDS Alliance for Children, Youth, and Families
Communities Advocating Emergency AIDS Relief
National Alliance of State and Territorial AIDS Directors
National Association of People With AIDS
National Minority AIDS Council
Project Inform

Recommendations Made by the Community Coalition on September 13, 2006:

Recommendations Endorsed By:
AIDS Action Council
AIDS Alliance for Children, Youth and Families
Communities Advocating Emergency AIDS Relief Coalition
National Alliance of State and Territorial AIDS Directors
National Association of People with AIDS
National Minority AIDS Council
Project Inform

Hold Harmless Provisions
There are areas of the country which appear to lose far more than 4 percent of funding under the bipartisan bicameral bill, particularly when Titles I, II, and Title I supplemental funding levels are included in calculations. Such losses will severely disable care and treatment systems upon which those living with HIV/AIDS depend. In particular, jurisdictions which are in good faith in transition to HIV name-based reporting will lose hold harmless status in three years. In the 1996 and 2000 reauthorizations, the concept of "hold harmless" was historically correlated with the age of the epidemic and therefore the presumed level of need of those living with HIV and AIDS. In the current House draft, it has been generally acknowledged that transition to a new reporting system can take significant time despite best efforts by state and local officials. A hold harmless provision for the full length of the reauthorization is essential to avoid loss of service to those in need of care and treatment as well as those receiving these services.

Funding Concerns
In order to ensure stabilization of current services and to meet the needs of the growing epidemic, we applaud the committee for adding additional funding to the Title II base. However, with the important changes to the ADAP supplemental, we believe there must be an increase in funding for the ADAP earmark to ensure that the increase in the setaside amount for the supplemental does not result in significant losses for other ADAP programs. Our coalition has endorsed a recommendation for higher authorization levels for each component of the CARE Act and annual increases tied to the rate of health care inflation and the overall cost of living.

EMA, Transitional Area and Emerging Community Eligibility
Eligible Metropolitan Areas (EMAs) with a significant burden of disease should remain eligible in Title I for the length of the reauthorization period. Many of the EMAs that would drop out of Tier 2 after three consecutive years under the September 7th draft have older epidemics. As a result, the people in the EMA who have been living with AIDS for more than five years are not counted towards EMA eligibility although they are being served. Eliminating Title I eligibility for these areas, many of which have a similar or greater number of actual living AIDS cases as new EMAs, would result in severe cuts to vital care, treatment, and support services for thousands of people living with HIV/AIDS. Therefore the coalition proposes:

Title I, Tier 1 (EMAs):
Eligibility for Tier 1 remains at the level in the September 7th draft EXCEPT if the jurisdiction has an AIDS prevalence rate of 3,000 or more actual living AIDS cases, the jurisdiction shall remain eligible for Tier 1.

Title I, Tier 2 (Transitional Areas):
Eligibility for Tier 2 remains at the level in the September 7th draft EXCEPT if the jurisdiction has an AIDS prevalence rate of 1,500 or more actual living AIDS cases, the jurisdiction shall remain eligible for Tier 2.

Title II, Emerging Communities:
Eligibility for Emerging Communities remains at the level in the September 7th draft EXCEPT if the jurisdiction has an AIDS prevalence rate of 750 or more actual living AIDS cases, the jurisdiction shall remain eligible as an Emerging Community.

Additionally, if a Title I, tier 2 EMA drops into Title II after three consecutive years we ask that it be made explicit that funding is allocated to the EMA’s respective state.

Title II Consortia Support
We ask that consortia-related expenses be counted in a states’ 25% support services pot, and not in the 10% administrative pot as suggested by the September 7th House bill. For 15 years, consortia have been one of the allowable program activities and expenses within Title II. States are not likely to be able to also absorb consortia costs within the administrative cap. We believe consortia expenses should continue to be an allowable program expense, under the support services pot.

Early Diagnosis Grant Program
As discussed in a letter of August 25 signed by many of our organizations, we are opposed to provisions which would authorize incentive grants for states that carve out existing resources from CDC HIV prevention funding. In spite of this opposition, we could accept such a provision that authorizes the grants ONLY using new money, and in subsequent years, the original appropriated money and any additional funding appropriated for the grant initiative. As this provision also appears to be in direct conflict with the President's Domestic HIV/AIDS Initiative which proposes increased funding for a broad-based testing initiative, we believe that potential incentive grants should have a wider set of eligibility criteria. Therefore, we would support the collapsing of the $30m authorization level so that the entire $30m may awarded to jurisdictions that comply with either of the two categories; related, funding per jurisdiction should be capped at no more than $2 million annually. Further, we recommend that the use of funds for "treatment of mothers infected with HIV/AIDS" be further targeted and replaced with "treatment for pregnant women to prevent perinatal transmission".

Formula Data Concerns
We understand that, for the purposes of formula funding distribution, the committee proposes to use the estimated HIV data reports from code based States and Eligible Metropolitan Areas included in their funding applications to HRSA. We would ask that this requirement be made explicit in statute as well as a requirement that HRSA establish a uniform methodology that track-two States and EMAs would be required to use to produce their HIV estimates. We remain concerned that the data runs from the Government Accountability Office (GAO) do not include any estimates on the impact to either EMA or State supplemental funding. Title I communities have come to rely on supplemental funding as an essential resource to sustain their systems of care and treatment. The impact of the new formula proposals on Title I and II supplemental funding is critical for all Members of Congress and their represented communities to assess the full impact of the proposed bill.

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