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Issue #151: November 16, 1997
FASTFAX is available by fax in the 215 and 610 area codes at no cost, or by mail anywhere for $20.00 per year, by calling 215-545-6868, and by E-mail by contacting and type the message SUBSCRIBE in the message section. Sources for some information in this issue include AIDS 1997, Associated Press, Chicago Defender, George Carter, Infreader@aol.com, Medical Meandering, NIAID News.
Major overhaul for AIDS case management: City to rebid $2.7m
Combo won't stop HIV replication: NIAID
FDA approves stronger saquinavir
Activists challenge Social Security changes
Major overhaul for AIDS case management: City to rebid $2.7m
The AIDS Activities Coordinating Office (AACO) plans a major effort to improve services delivered through the AIDS case management system beginning next March, after re-allocating over $2.7 million of federal and local funds which support the services.The reallocation represents the first effort by the Health Department to reorganize the AIDS case management system since funding was first provided in 1988. Since that time, most funding for case management services was awarded to existing organizations in place at that time so that they could expand their efforts as the numbers of people with AIDS increased.
The city has issued a "Request for Proposals" which requires all case management agencies to meet new "Standards for HIV/AIDS Case Management" issued by the Commonwealth of Pennsylvania, and also requires participation in a "continuous quality improvement" (CQI) project being sponsored by the city. The state standards were developed after consultation between local and state health authorities, case managers, and consumers since 1994, and the CQI measures were adopted through a planning process implemented last spring and summer.
Agencies which seek to begin or continue their case management activities must respond to the city's request by December 1st.
For the first time since the epidemic began, the city will utilize standards will require specific credentials and certification for individuals providing case management services. The also more strictly define the specific services a consumer can expect from an AIDS case manager, and spell out the rights of consumers in the system.
Also for the first time, the new standards define what are called "acuity" levels, to better define what services are appropriate for people at various levels of HIV disease.
AACO has announced that it will set up a "regional uniform access system" for case management services, which will help individuals choose an appropriate case manager and, perhaps more importantly, help consumers who have only a transitional need obtain services without having to become a formal client of the case management system. AACO hopes through this process to alleviate the long waiting lists which have developed for case management services at some agencies, and reduce the steps and delays many consumers have experienced in accessing services.
Linking clear performance standards with AIDS case management funding has been a high priority of AIDS advocates for almost a decade. Many AIDS advocates have complained that AIDS case management services have been slow to change as the epidemic has expanded, and that there has been little accountability or evaluation of the effectiveness of the services. Others have objected to the amount of funding needed to support case management services, which in their view results in less funding for medical care and practical supports such as medications, food and housing assistance.
Politics has also played a significant role in how the case management system has developed. Most of the early AIDS organizations were primarily organized around case management services, and some believe those organizations sought to control AIDS allocations in the region to prevent providers of other services from being able to build their capacity or develop competitive organizations. For much of the last ten years, the leadership of the AIDS service system has been drawn from AIDS case management agencies, which some have charged has led to bias and conflict of interest in the allocation of AIDS resources.
Over half of the total number of AIDS case managers in the region work for ActionAIDS, the city's largest AIDS service organization, which has also been the only agency which receives local general funds for its case management activities. Other organizations performing case management services have had depend on small incremental grants from federal funding, which has been much more restrictive in its requirements and less flexible in terms of overhead and administrative costs.
Still others, mostly from minority communities, have complained that efforts in communities of color to develop case management services have been hampered by the city's unwillingness, until now, to allow for a broad competition for available funds from all agencies. Only about 15 AIDS case managers work for minority organizations in the region, out of a total of over 100 case managers supported by public funds.
The re-competition for AIDS case management funding was announced earlier this summer by Joseph Cronauer and Patricia Bass, interim co-director of AACO. Cronauer has said that the city intends to routinely re-bid its AIDS funding contracts in all service areas every few years. Case management services were chosen early because a consensus on standards and CQI measures was achieved this year.
The challenge facing AACO as it seeks to implement the new standards are enormous. While the city has supported a variety of approaches to social services for people with HIV/AIDS through its case management funding in the past, new federal requirements put more severe restrictions on what the funding can be used for, and the case management budget will now be solely dedicated to "formal" and traditional social work efforts. Smaller organizations, especially those providing short-term or crisis-oriented case management services, have expressed concern that they may not be able to meet the paperwork and administrative burden of the new standards, and that more flexible case management services may be de-emphasized over time.
AACO says that it will be issuing a request for proposals for other categories of funding, including "care access field specialists" and "client advocacy," which will be able to support some of those activities in the future.
While generally supporting AACO's efforts to rationalize the AIDS case management system, many minority advocates are concerned that because of the higher standards now in place, newer minority case management groups may not be able to effectively compete in the current funding cycle. They worry that while AACO has clearly indicated its intention to expand case management services in minority communities, the outcome of the current competition for funding will result in fewer minority organizations being funded. Most of the ire on this concern, however, has been directed to the Minority AIDS Project of Philadelphia, which has failed to provide technical assistance and support to minority case management agencies to prepare for the new standards.
MAPP was asked by AACO this summer to work with minority organizations to help them evaluate what changes they would need to make to qualify for continued funding, as well as to develop a network of agencies which could seek reimbursement from Medicaid HMOs for case management services to their members. However, none of the minority case management agencies which receive their funding through MAPP had been contacted by MAPP for this assistance until a meeting held on November 13th, only seventeen days before the proposal deadline.
At that meeting, MAPP encouraged a small group of neighborhood-based AIDS prevention organizations to join in a MAPP-sponsored coalition to apply for the case management funds. Most organizations at the meeting were non-committal, however, and several questioned MAPP's capacity to manage such a network.
MAPP receives about $500,000 to provide "capacity building" and "technical assistance" to minority AIDS organizations, but spends about $380,000 of that amount on staff which administers contracts and monitors budgets. MAPP claims that it has already obligated the remaining funds for other technical assistance activities and no funds remained for developing case management capacity or helping minority case management agencies apply for the funding.
Two of the minority case management agencies which receive their funding through MAPP, BEBASHI and the Craig Foundation, pulled out of the network in 1995, citing concerns about MAPP's management of their funds. Congreso de Latinos Unidos, which provides the bulk of AIDS case management for the city's Puerto Rican and Latino population, also stopped participating in MAPP in 1995, as did We The People earlier this year. At the present time, only two organizations receiving case management funding -- Unity, Inc., and YO-ACAP, a youth HIV prevention group -- continue to participate in MAPP's activities.
AACO has also announced that it intends to re-bid MAPP's technical assistance funding next spring, along with almost $3 million in HIV prevention funding.
Combo won't stop HIV replication: NIAID
HIV persists and can replicate in HIV+ people who have no detectable virus in their blood as a result of combination antiretroviral therapy, according to a new report from researchers at the National Institute of Allergy and Infectious Diseases (NIAID).The report raises important questions about whether the new therapies will continue to be effective over time.
The researchers said that their findings indicate that a "reservoir" of HIV exists in infected patients despite prolonged treatment with highly active antiretroviral therapy (HAART), which usually includes a protease inhibitor and two "nucleoside analogues" such as AZT and 3TC and similar drugs. They said their data suggests that "the time required for eradication of HIV from the body, if indeed possible, may be considerably longer than previously predicted," according to Tae-Wook Chun, Ph.D., of NIAID's Laboratory of Immunoregulation (LIR).
NIAID director Anthony S. Fauci, M.D. said that "These results underscore the importance of developing more potent antiretroviral drugs, as well as treatment strategies that specifically target latently infected cells that serve as hiding places for the virus. Although our current armamentarium of antiretroviral drugs has served many patients well, at least in the short-term, more progress must be made in the area of HIV therapeutics if we are to speak of a cure for HIV disease."
In their experiments, the researchers studied 12 HIV-infected patients who were taking three-drug antiretroviral regimens consisting of a protease inhibitor (indinavir, ritonavir or saquinavir) combined with two nucleoside analogues (3TC, d4T, AZT or ddI). A thirteenth patient received two protease inhibitors and two nucleoside analogues. These 13 patients had been taking HAART for an average of 10 months. In addition, four HIV-infected patients receiving no therapy and one taking 3TC only were included in the study population.
Of the 13 patients receiving HAART, nine had levels of HIV RNA in their plasma below 500 copies/cubic milliliter (ml), the detection limit of the branched DNA (bDNA) assay used in the study.
The researchers isolated highly purified, resting CD4+ T cells from all 18 patients, and used a sensitive laboratory technique called the polymerase chain reaction to detect HIV DNA in an integrated form (i.e., inserted into the genes) in cells from each individual.
"Interestingly, levels of integrated HIV DNA were not significantly higher in untreated patients than in HAART-treated individuals," notes Dr. Chun. "As others have postulated, this finding suggests that resting CD4+ T cells with integrated DNA do not decay rapidly in patients receiving HAART, and therefore may serve as a stable 'reservoir' of virus."
In addition to integrated HIV DNA, the investigators found unintegrated DNA in cells from all patients.
The presence of unintegrated HIV DNA suggests that the virus continues to replicate, although at lower levels, "even in the setting of HAART," noted Fauci. "In HAART-treated patients, we found that levels of unintegrated HIV DNA were 28 times higher than integrated HIV DNA levels. This suggests that even when HIV is undetectable in the plasma, a low degree of viral replication contributes to the maintenance of a reservoir of HIV- infected CD4+ T cells."
FDA approves stronger saquinavir
The Food and Drug Administration has approved a more powerful version of the protease inhibitor saquinavir, setting the stage for thousands of AIDS patients to switch from the weaker version marketed last year.Hoffman-La Roche's Fortovase, the improved version of the protease inhibitor saquinavir, will be on pharmacy shelves the week of Nov. 17. The company said it will cost the same as Invirase, the old brand of saquinavir -- about $5,700 a year wholesale.
Saquinavir was the first of the protease inhibitor to hit the market, in December 1995. But at the time, the FDA cautioned that saquinavir was the weakest of these new drugs, and Roche immediately began strengthening it.
The new Fortovase version comes in a soft gelatin capsule that delivers more drug through the body than Invirase, the FDA said.
One study showed that after 16 weeks of treatment, twice as many patients who took Fortovase had undetectable levels of HIV in their blood as did patients who took Invirase, the FDA said.
The reason? The original hard capsule of Invirase took so long to dissolve in the digestive tract that enzymes had a chance to degrade it, leaving less to enter the bloodstream and fight HIV.
The soft formula combines the drug with an oil-like substance that is rapidly digested, so more medicine can get to the bloodstream, Roche said.
The FDA said Fortovase's side effects are similar to those of Invirase, including diarrhea, nausea and abdominal discomfort.
Roche will continue to sell the older Invirase for six months, giving the 40,000 Americans now taking Invirase time to switch to the new formula. The company recommended that patients consult their physicians to determine if and when to switch.
"We're hoping that most people will switch," said Roche's Dr. Sandy Palleja. "There are many patients doing well on the current formulation. ... Those patients would have a more durable effect" on Fortovase.
But Roche pledged to make limited amounts of Invirase available if some doctors decide not to change their patients' medicines.
AIDS experts recommend that most patients take combinations of drugs that generally include one protease inhibitor with two other types of anti-HIV medications. The dosage of Fortovase is 1,200 milligrams taken three times a day with meals.
NMAC marks 10th anniversary
The National Minority Aids Council (NMAC) will be hosting a fund-raising dinner on Dec. 2 to mark the organization's 10th anniversary.NMAC is the nation's premier HIV/AIDS organization specifically addressing the needs of communities of color fighting AIDS on the front lines. Throughout its 10-year history, NMAC has provided its constituents with award-winning conferences, technical assistance, public policy and leadership, publications and media campaigns. The goal of the organization is to develop leadership to address the issues of HIV/AIDS within the communities it serves. "As we reached this milestone in our history, it was clear that a celebration was not in order," said Norm Nickens, NMAC's board chair. "Though AIDS death rates have dropped dramatically among Caucasians, communities of color and women continue to be disproportionately affected by this epidemic.
"The theme of the 10th anniversary is 'Still Fighting For Our Lives', and that has never been more true," explained NMAC's Executive Director Paul Kawata. "We have chosen to commemorate those we have lost to this epidemic as well as offer our support and encouragement to those individuals continuing in the struggle." The dinner will serve as a benefit for NMAC's Women and Families program which addresses the needs of women of color and their families through a variety of education and public policy initiatives.
"We are committed. We are driven, We will not back down," Kawata emphasized. "NMAC is committed to ensuring that people of color across the country and throughout the world have the same opportunities for prevention, care, treatment, education and financial resources as anyone else."
For tickets and sponsorship opportunities, contact NMAC at (202) 483-6622.
Activists challenge Social Security changes
AIDS activist George Carter, in a posting on the advocate Internet site AIDSAct, says that recently proposed changes to how the Social Security Administration (SSA) determines eligibility are intended to "clearly ... try to make it harder for someone to be found disabled."People with HIV-related symptoms have increasingly complained that as the epidemic has expanded, the SSA has become more restrictive in allowing HIV+ people to qualify for Social Security disability payments, which for most PWAs amount to about $6000 per year.
The proposed regulations state that special consideration must be given to the opinion of a physician employed by Social Security. The regulation strongly implies that the opinion of Social Security's doctor is more important than the opinion of the treating doctor.
62 Fed Reg 50270 contains a proposed rule that would require administrative law judges and appeals councils hearing SSA disability cases to start giving more weight to the "opinions and findings by nonexamining state agency medical personnel and medical experts they utilize." This is accomplished by adding two new factors to the list of criteria that can affect the weight given to medical opinion: a) the amount of SS disability programs expertise the resource has; and b) whether a source reviewed the claimants entire case record before providing a medical opinion.
"What Social Security is trying to do is to put a heavy hand on the scales of justice to weigh them towards denying claims by making the opinion of their own in-house doctor more important than the opinion of your own doctor who has been treating you. This is in response to many court decisions saying the exact opposite," Carter wrote.
Carter recommends that advocates write to the Social Security Commissioner, P.O. Box 1586, Baltimore, MD 21235 to express opposition to the proposal. Email comments can be addressed to regulations@ssa.gov, and faxes to (410)-966-2830.
Ethel Zelenske, staff attorney at the National Senior Citizens Law Center, the leading Social Security advocacy group, said that "Sending comments is the best thing that your members can do. I think it is a great idea that they explain in their own words why the proposed regulations are a bad idea."
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