Roche and Abbott to conduct combo study of protease drugs
Bucks County AIDS home passes legal hurdle
WTP restructures, hire management team
TPAC committee asks for reconsideration of groups future
Suburban group seeks to strengthen regional planning process
Test helps tell it mother will pass HIV to child
It is hoped that, when administered together, the two treatments will be more effective in treating HIV/AIDS than either treatment alone, without sacrificing safety.
In vitro and animal data indicate that Norvir dramatically increases blood levels of Invirase. It does this by inhibiting the liver enzyme responsible for the fast metabolism of Invirase. Blood levels of Norvir are not significantly affected by Invirase.
"The community was anxious for this study to begin, although it should have been started months ago. We are hopeful that this combination will be a potent therapy that will slow the replication of HIV. For individuals who have used up treatment options, the possibility of combining two drugs, never before taken, is encouraging," said Jules Levin, director, National AIDS Treatment Advocacy Program. "The community wants studies quickly to examine other combinations of two protease inhibitors, both for safety and efficacy. Safety studies are paramount, because soon five protease inhibitors will be available either as approved drugs or in clinical trials," he added.
Invirase has a distinct and consistent mutation profile, which means that it is unlikely to accelerate the onset of resistance (reduced sensitivity) to Norvir. The most frequently reported adverse events with Invirase occurred in less than four percent of patients and were gastrointestinal, including diarrhea, abdominal discomfort and nausea.
"We are excited by the opportunity to work with Abbott to determine whether clinical experience will confirm the preliminary pharmacokinetic data now available," said Miklos P. Salgo, M.D., Ph.D., director of virology, Hoffmann-La Roche. "It is still early, but we are hopeful that combinations of protease inhibitors will eventually represent an important treatment option for people living with AIDS."
Abbott Laboratories submitted a New Drug Application to the U.S. Food and Drug Administration for Norvir in December 1995. Invirase was cleared for marketing by the FDA in the same month.
Trials are currently underway to determine safety data. Once safety is determined, plans will be announced regarding clinical trials to determine efficacy of these compounds in people with AIDS.
Merck's protease inhibitor, Crixivan -- believed to be the most effective of the protease options -- is expected to become available over the next several months.
Resistance to protease inhibitors
Researchers may be able to help doctors treat people with AIDS with protease inhibitors thanks to new studies of HIV resistance to the drugs.
Scientists at the Aaron Diamond AIDS Research Center in New York have identified specific locations on the HIV protease gene where drug resistance-causing mutations occur. With this new information, experts now advise doctors to be aggressive with the drugs, not to skip doses, and to stick to the dosage scheduled. The scientists said that combining protease inhibitors may keep the mutation dominance from happening.
Bucks Villa is a project supported from a variety of federal and county housing agencies and being developed by Family Service Association of Bucks County.
The Commonwealth Court decision ruled that the group home is the "functional equivalent of a traditional family" and therefore cannot be prohibited from being located in a residential neighborhood.
Hary L. Eichlin, a neighbor of the proposed site, had led the effort against the home because he said that the group of residents could not be considered a "family," and that the program, which emphasizes independent living, would not provide nursing and medical services.
Audrey Tucker, FSABC executive director, was quoted by President Judge James Gardner Collins as saying that "even though children will not be raised in the home, the group home in this case will exhibit the characteristics of affection and companionship common in a traditional family."
Eichlin, who said he pursued the case against Bucks Villa because it had been started by his now-deceased wife, said that he was unsure whether he would appeal. He told the Bucks County Courier-Times that he has already spent over $20,000 on the case.
Meanwhile, in January, the New Mexico Supreme Court issued a similar ruling that a small group home for persons living with AIDS was a legitimate use in a single family neighborhood, and its continued operation was protected and allowable under the Fair Housing Act Amendments of 1988. The Protection and Advocacy System of New Mexico was the lead counsel in the case.
The ruling came on an appeal of a state district court order to close the home, administered by a religious organization, based on findings that the Fair Housing Act did not apply and that operation of the group home violated the restrictive covenants of the Four Hills subdivision. The state Supreme Court had previously stayed any enforcement of the lower court's order. The case is Hill et al. v. the Community of Damien et al.
The ruling is important because the state Supreme Court went to great lengths to explain why the Fair Housing Act applied to this case. Key points in the high court's order include:
*confirmation that AIDS is a disability for purposes of civil rights legislation such as the Fair Housing Act.
*even if no discrimination is intended, enforcement of an apparently "neutral" land use restriction violates the Fair Housing Act if it has a "disparate impact" on persons with disabilities. In this case, exclusion of any congregate living arrangement, irrespective of whether it involved people with disabilities or not, could prevent persons with AIDS from living in a family style setting in the community of their choice.
*"reasonable accommodation" is required under the Act to provide equal opportunity for persons with disabilities. Choosing not to enforce a restriction which would harm people with disabilities much more than other persons would be a reasonable accommodation in these circumstances.
The Supreme Court also ruled that the group home was not in violation of the subdivision's covenants limiting land use to single family homes, as contended by the neighbors. The court found that it fit within the definition of "single family" within the city of Albuquerque's zoning ordinance, that it was not a commercial enterprise even though it was administered by a non-profit corporation and utilized in-home staff care, and that public policy required an expansive definition of single family use in order to promote community integration of persons with disabilities, including persons with AIDS.
Since these rulings alone could have resolved the dispute in favor of the group home residents, the Supreme Court's decision to correct the lower court's misinterpretation of the Fair Housing Act was especially noteworthy and helpful to efforts to stop AIDS housing discrimination.
In response to the David Fair's notice of departure as Executive Director effective March 1st, WTP's Board of Directors formed a Search Committee and initiated a search for a new Executive Director. Of the thirty five responses, the Committee chose to forward to the Board a joint proposal from Cronauer, Blackwell and Cason which shifts some responsibilities from the Executive Director to the newly created positions of Fiscal Director and Operations Director. The purpose of the shift is to create a management team who work in collaboration on the various aspects of the organization.
According to the proposal submitted by the group, "We believe that, in keeping with the model of collaboration and empowerment in place at We The People, the best way to proceed in filling the position of Executive Director is to restructure We The People's management structure to build on the strengths, abilities and dedication that already exists within the management and organization in a way that more equally distributes management responsibilities. Such a structure makes sense in light of the emphasis we have always placed on self-empowerment and teamwork, and allows for a more open and collaborative decision-making environment in a world where our decisions are likely to become even more difficult and complex than we have experienced in the past. In this way, we can all move forward together to meet the goals, mission and policy of our members as established and brought forth through the Board of Directors and implemented by the staff."
Under the new structure, Cronauer will be responsible for working in collaboration with the Operations Director and Fiscal Director to ensure general oversight and supervision of all We The People programs, activities and fiscal matters, as well as all education activities, political advocacy, funding proposals, housing programs, subsidiary and sister organizations, etc. Cason will be responsible for all physical operations of the Life Center and all of its related programs, including the supervision of the Member Services Coordinator and the Housing Coordinator. Blackwell will be responsible for all fiscal aspects of the organization, including budgets, invoices, contracts, monthly reports, payroll, financial statements, etc.
Previous to the restructuring, Joe Cronauer served for two years as Director of Education Services for WTP, primarily responsible for the fifty-member Positive Voices Outreach Team, fastfax, Alive & Kicking!, and the weekly television show Positive Health. He has been active in local AIDS planning and politics, serving on a variety of committees and workgroups including the Board of Directors of TPAC and the city's new Community Planning Group of which he is a Co-Chair. Prior to his position of Director of Education Services, Cronauer volunteered in a variety of ways at We The People, including as receptionist, a Positive Voices member, and at one time as Associate Secretary/Treasurer of WTP's Board. Cronauer has been a member of We The People for four years, shortly after he was diagnosed as living with HIV disease.
Billy Blackwell has served as Administrative Coordinator for WTP for the last two years, and has been with WTP for about four years. As Administrative Coordinator, he was responsible for a variety of administrative and fiscal areas, playing a crucial role in helping to coordinate the administrative and fiscal aspects of the organization so that the vast majority of the budget could be spent on direct services for members. Prior to being Administrator, Blackwell held several other titles, including Program Coordinator and Life Center Assistant.
Sabrina H. Cason, a well-known activist on several issues, came to the organization three years ago with a vast amount of experience in the areas of housing and domestic violence. She began as Housing Counselor, and was promoted recently to the position of Deputy Executive Director, and as such was directly responsible for all day-to-day operations of the Life Center, which now has over 3,000 visits per month and a calendar with over 250 events and activities every month.
All three stated after the meeting that they are excited to begin the collaborative effort, which emphasizes their individual strengths as well as the strengths of the organization. According to Cronauer, "David (Fair) gave us quite an act to follow. He really helped us -- both the Board and our membership -- build this organization. Billy and Sabrina are very talented and committed people, and I know this organization is in safe hands as we work with the Board to continue to serve those of us who are least served by the rest of the AIDS system."
The issue of TPAC restructuring came as a result of last year's decision by Health Commissioner Estelle Richman to pull from TPAC the role of Ryan White Title I planning council and move that responsibility to the city's newly formed HIV Commission. As Title I planning council, TPAC was at one time responsible for the planning and allocations of all of the city's Ryan White money that was allocated directly to the city to meet the needs of people living with HIV disease. Removing TPAC from that role came after months of severe criticism of TPAC by minority and AIDS consumer groups in the city which charged TPAC with incompetence and conflict of interest in performing that role. Many members of the TPAC Board work for agencies which ultimately benefited from the planning, priorities and allocations decisions under TPAC's control, in violation of state contract provisions which prohibit grant recipients from serving on AIDS planning councils.
Currently at issue is TPAC's role as Title II planning council, which makes the organization responsible for the planning and allocation of Ryan White money awarded to the state of Pennsylvania for distribution to the state's five-county southeastern region. Many critics of TPAC performing this role have pointed out that the same conflict of interest issues remain with TPAC when it comes to the planning and allocations of Title II money as existed with the Title I funds. Many TPAC board members have charged that the allocations processes that TPAC has been responsible for in the past have met with major community opposition, who claim that the allocations have ignored the communities and priorities which the Board has set up as most important.
TPAC leadership requested, and were granted, an "exception" to state contract provisions prohibiting conflicts of interest in the planning and allocation process, but never obtained approval of the TPAC board for that request.
Some TPAC board members have criticized the diversion of AIDS service dollars to a second planning process that will likely be duplicative of the process used by the better-funded HIV Commission. Others have noted that TPAC will be unable to operate a legitimate Title II planning process in any case, because it there are insufficient funds available from Title II to conduct serious planning.
Despite public claims to the contrary by TPAC Treasurer Alan Edelstein at a recent meeting of the newly-formed Suburban HIV/AIDS Consortium, AACO Director Jesse Milan confirmed at the February 27th meeting of the HIV Commission that he informed TPAC as early as last September that all Title I administrative money currently being received by TPAC for planning purposes will be moved to the HIV Commission this April.
Other reports said that the federal Health Resources and Services Administration, which distributed Ryan White funding, has informed the state of a cut in Title II funds which might require the downsizing or elimination of Title II planning councils like TPAC around the country.
Many members of the TPAC Board, as well as many community members from minority groups, expressed their approval of the Board "revisiting" the issue of whether TPAC should be engaged in the planning and allocations of AIDS money, no matter what the source of that money. Many on both sides of the issue acknowledge the need to address the issue directly. At the last specially scheduled Board meeting, only about half the Board members were present, and only just over half of the members present voted in favor of keeping all functions which TPAC currently has, without specifically addressing the issue of planning and allocations.
At press time, there has been no public response to the request directed to the TPAC Co-Chairs.
The requests were presented at the HIV Commission's February 26 meeting, at which SHAC convener and Commission member Dan Daniel presented to Jesse Milan, Jr., Director of AACO, and Sonya Hunt Gray, HIV Commission Manager, a letter jointly addressed to them. The letter was subsequently read into the record of that meeting by SHAC and HIV Commission member and consumer Bob Long. The three requests were:
1. That the HIV Commission, which is the federally mandated Ryan White Title I Planning Council, appoint a staff person to attend regular scheduled SHAC meeting and to serve as liaison between SHAC and the planning council;
2. That the planning council correct and improve the significant lack of information about Bucks, Chester, Delaware and Montgomery counties presented in the CARE Act supplemental application submitted by the City of Philadelphia; and
3. That the planning council dedicate specific resources (e.g., staff, planning dollars, technical assistance, etc.) for use by the four suburban counties.
A deadline of March 20 was set for these requests to be met or for a time line to be established for their implementation. The letter was signed by 14 service providers and consumers representing Bucks, Chester, Delaware and Montgomery counties, four of whom are also members of the HIV Commission.
There was no immediate response to the SHAC letter, though several HIV Commission members commented that the letter was quite specific in its requests and detailed in terms of what was needed and that time was needed to consider the requests. Commission manager Sonya Hunt Gray agreed to see that the letter was duplicated and circulated to Commission members prior to the next meeting on March 20.
A similar letter was to have been sent to The Philadelphia AIDS Consortium, which is the state-designated Ryan White Title II Planning Council. However Jesse Milan, in response to questions by Dan Daniel, confirmed at the February 26 HIV Commission meeting that TPAC will lose all of its Title I funds, almost a half-million dollars, which had previously been used to support TPAC administrative functions, by April 3. The Title I funds will be shifted to form the bulk of the budget for the HIV Commission. The result of this for TPAC is that they will have no choice but to cut staff and reduce the number and scope of functions they perform. In light of this, SHAC decided to hold its letter to TPAC in abeyance for the time being.
"It seems clear," Daniel said with regard to the decision to hold back on the TPAC letter, "that the shift of nearly half a million dollars away from TPAC will leave them in such a weakened position that they will be unable to accomplish the functions of the planning council. Because the majority of Title II funds go to the suburban counties, this alarms us. If TPAC is left so weakened as to be unable to do the planning, contracting and other activities it has heretofore been responsible for, what impact will that have on consumers and service providers in our four counties?"
Daniel added that the issue of what will now become of the Title II planning council will be on the agenda for the March 27 SHAC meeting.
Los Angeles Daily News
Doctors have developed a test to help better predict whether pregnant women will pass HIV to their unborn children, UCLA researchers have announced.
The test measures the amount HIV genetic material called RNA, or ribonucleic acid, in the mother's blood.
"Use of our RNA testing in pregnant women will help guide us to future strategies for therapy, particularly in women at high risk of transmission," Dr. Yvonne Bryson, the principal investigator of the study said Tuesday.
Despite its success, Bryson cautioned that the test cannot predict with certainty the likelihood of transmission for reasons including that it could be passed to the child in the course of delivery.
"It is one of the better predictors we have right now, but obviously not perfect," said Bryson, a professor of pediatric infectious diseases at the University of California, Los Angeles. The research, co-investigated by Ruth Dickover at UCLA, is reported in today's issue of The Journal of the American Medical Association.
The study bolsters earlier research that singled out the anti-AIDS drug AZT for its ability to keep some children infection free by significantly cutting the amount of virus in the mother's blood.
"Virus load is important for risk of transmission. AZT is important for reducing it," Bryson said. "Unfortunately, it is not totally predictable; if one has a low viral load, it can change or something could happen at delivery."
The four-year study tracked 92 women infected with the AIDS virus and their 97 newborn children, 20 of whom became infected.
As a result, it appears the 1996 elections will decide the country's direction on Medicaid and other social policy issues. For adults and children with mental or emotional disabilities who rely on various public programs for essential services and supports, the ultimate outcome of this national debate on government responsibility will be critical.
Plans Differ on Spending Cuts
All three parties propose significant spending cuts. Congressional leaders initially sought reductions of $186 billion over seven years, but gradually dropped their demands to $85 billion in cuts over the same period. The President's most recent proposal cut $59 billion. The Governors did not specify the level of federal cuts as clearly, but their plan greatly reduces a state's contribution, thus increasing the impact of any federal cuts by allowing states to draw down federal Medicaid dollars while spending less of their own money.
Cuts at any of these levels would clearly reduce access to covered services and would undermine Medicaid's ability to offset the already occuring loss of employer-sponsored health care coverage. During the past five years, the number of people covered by insurance fell by 5.9%; many of these formerly insured individuals and families account for the 3.9% rise in the Medicaid-covered population over the same period.
Policy Differences Are Deep
Varying levels of funding cuts, however, are only one reason for the current impasse. Any agreement would have to bridge a wide policy gap, between a block grant to states and continuation of the current Medicaid entitlement.
Congress and the Governors have proposed a block grant to the states, although the Governors' plan contains more assurances than Congress' that states will be able to draw down the federal funds they need.
In contrast, President Clinton and congressional Democrats have sponsored a capped entitlement, which would guarantee certain individuals coverage of a basic set of mandated services, similar to the current law, but caps the federal government's total spending for Medicaid.
Under both Congress' and the Governors' proposals, people with disabilities (defined federally as those who receive SSI benefits) would lose the federal guarantee of access to Medicaid. Instead, states would write their own definitions of disability, although they would still be required to include this category of eligibility in their plan.
As the competition intensifies for limited dollars at the state level, such flexibility could harm many people with mental illness if stigma and misunderstanding lead states to exclude their conditions from the definitions of disability.
Adolescents would also lose guaranteed eligibility under both the Governors' and the congressional leaders' plans, which only require coverage for children through age 12 in poverty families.
Many Could Lose Services
An important difference between the plans is that the President proposes to retain the current set of mandated and optional services, while the congressional bill mandates only child immunizations and certain family planning services. It also amends the list of optional covered services, putting community-based mental health services at risk (although states would have flexibility to add any health service they choose). The Governors have a hybrid plan that mandates some, but not all, of the current mandatory services and retains all current options.
The block grant's flexibility would mean that children would no longer be guaranteed treatment for any condition found as a result of a Medicaid screen. The congressional plan would repeal Early, Periodic Screening, Diagnosis and Treatment (EPSDT), while the Governors' plan would remove the requirement for treatment.
The President, while not proposing a block grant, also urges greater flexibility for states in certain aspects of Medicaid, such as being able to use managed care and home- and community-based services without a federal waiver.
A Critical Few Weeks
The next few months are critical to the outcome of this debate on Medicaid. For low-income people with mental illness, the President's capped-entitlement plan has significant advantages over a state block grant. It would better protect their eligibility for Medicaid and their access to current mental health services. In addition, the President's cuts are not as deep as Congress' and his plan would require states to continue spending at today's rate to secure federal matching funds.
What You Can Do
1. Call your members of Congress, especially your Senators, at 202/224-3121, and urge them:
--to retain Medicaid as a capped entitlement;
--not to cut Medicaid spending excessively;
--to require states to cover people with disabilities who meet the federal definition in SSI law; and
--to reject the block grant approach of the National Governors Association and the proposed congressional leaders' plan.
2. Call the President - Call 202/456-1111 to reach the White House comment line, and urge the President:
--not to compromise on the essential principles of a capped entitlement for Medicaid;
--protect the eligibility of people with disabilities who receive SSI benefits; and
--not to agree to cuts any larger than $59 billion over seven years.