City will keep AIDS services going -- briefly -- while cuts are debated
Cutback partly caused by city "misrepresentation," MAC says
Ridge Medicaid plan rejected by House
Study says some have HIV resistance
Amplicor gets FDA committee nod
Researcher warns of second epidemic
Conference reports emphasize importance of avoiding stress
HIV life cycle more rapid than previously reported
FDA: more patients to try hyperthermia
AIDS Activities Coordinating Office director Jesse Milan also announced that the city health department would allocate $157,000 to keep the programs affected by the federal cut operating at current levels for thirty days, to give the Commission and the communities affected a little bit of breathing room to decide how the address the impending cuts.
The federal funding reduction is officially effective next Wednesday.
At the meeting, which was attended by the Commission and its CARE Committee as well as many people living with HIV disease and representatives of most AIDS service providers, Milan explained that in the competitive process through which major cities like Philadelphia compete for additional Ryan White CARE money, Philadelphia fared poorly for the first time, losing over $1.8 million dollars of money already being used to care for people living with HIV disease. Milan said at the meeting that it was unclear from information available to him at the time how much of Philadelphia's poor showing was related to the quality of Philadelphia's application and how much was related to federal budget considerations.
The Health Resources and Services Administration, which allocates Ryan White funds, had previously warned that some regions would suffer cuts in funding for the coming year because the federal CARE budget has not been significantly increased, even though the spread of the epidemic requires HRSA to expand its funding to cover new cities not previously supported through CARE Act funds. Additionally, continued confusion in Washington in light of the failure of the Congress to pass a federal budget for this year -- and the fact that the CARE Act has still not been formally reauthorized by the Congress -- also affected this year's allocations, according to HRSA sources.
Minority AIDS advocates have complained that another reason for the cut in Philadelphia's grant was the "misrepresentation" by AACO policy analyst Jennifer Kolker, who wrote the city's Ryan White application, of certain minority community AIDS case management activities as "prevention education" services, which are not eligible for Ryan White support. [See accompanying article.]
On the short list of immediate cuts approved by the Commission at this week's meeting was almost $190,000 from AACO and from the Commission for various administrative functions not directly related to AIDS care.
In addition, federal officials asked the city to eliminate CARE Act funding for expenses related to the operations of the Resource Allocations Advisory Committee -- the group which make agency-specific AIDS funding recommendations to the Health Commissioner. This savings amounted to almost $33,000.
Milan said that substance abuse treatment also no longer qualifies as an allowable service provided through Ryan White funding, so the $59,706 budget for this service was eliminated.
Also trimmed or eliminated were case management coordination ($15,486), clinical care needs assessment ($20,700), and regional food coordination ($14,142).
Milan said that the city application had also included about $101,000 which had not yet be allocated to a particular service or agency.
Ambulatory health services at city health centers, which may be reimbursable through means other than Ryan White, may be on the chopping block pending the determination of the dollar amount that may be saved by pursuing alternate funding.
At the uncharacteristically civil meeting, there seemed to be a consensus among those who were speaking -- a combination of Commission members, AIDS service providers and consumers -- that an administrative cap of anywhere from five to ten percent across all Ryan White contracts would be another fair way to save money and rectify the large administrative percentage taken by some services providers off the top of their AIDS services contracts.
There also seemed to be an emerging theme that whatever the solution, it should be applied across the spectrum of AIDS funding sources. This theme is particularly prominent in organizations serving communities of color, since these were the last of the organizations to be funded as the first and larger AIDS organizations had their funding moved into the more stable "formula" contracts. Therefore, according to these agencies, considering cutting only supplemental contracts would cripple the fragile services network just set up for communities of color, which now compose about 70% of the AIDS cases in the Philadelphia region.
A conversation also arose at the meeting that some services such as risk reduction intervention may be a prevention service and therefore may not qualify as a Ryan White eligible service, and should be eliminated from the Ryan White budget. Others complained that risk reduction intervention is indeed a Ryan White service existing as part of the case management system, providing services and links to services to traditionally underserved and disenfranchised people living with HIV disease. The problem, according to Joe Cronauer, executive director of We The People, is that "the author of the application just didn't understand what risk reduction intervention means, and didn't bother to ask anyone. It's no coincidence that for the first time the application was written in complete isolation from the community by someone who many of us believe to be incompetent, and for the first time Philadelphia takes a $1.8 million hit."
Tension also filled the room as some service providers from minority organizations, including James Roberts, executive director of the Minority AIDS Project of Philadelphia, pointed out during their comments that other organizations have a much greater capacity to do large private fundraisers, such as the upcoming AIDS Ride. Those organizations who do not have the capital to invest in or who are not allowed to participate in such fundraisers are more dependent on public money such as Ryan White, and should be given preference, Roberts said.
A motion to hold a series of public hearings across the Philadelphia region over the next 14 days also passed a vote of the Commission. The hearings will be announced shortly and will be available to "all impacted communities".
Also passed by the Commission was a three-part motion which directs the groups Co-Chairs, Dr. Ted Kirk and Guy Weston, to pursue private local foundations for short term and long term assistance for the Ryan White system. Additionally, "umbrella" or "pass-through" organizations, which act as a pass-through for AIDS money from the city to individual service providers and are paid an administrative fee, will be asked to "...voluntarily assess their budgets for possible savings." Finally, the Commission asked its lead staff person, Sonya Hunt Gray, to investigate the Commission's own budget, believed by many to be lavish, for possible additional savings.
According to Cronauer, "I think I echo the thoughts of a lot of people when I say that it was a surprisingly good start. Many of us have been doing a lot with virtually nothing for years, while others have lots of money with little output. If moves like an administrative cap level this out and are spread throughout the system without affecting direct services, we can probably all live with that. If they single out minority organizations or the services our people need to stay alive, then we'll fight by any means necessary like we've always had to do just to stay alive."
A letter from the Health Resources and Services Administration (HRSA), which distributes federal AIDS care dollars, notes that federal legal counsel has determined that Ryan White funds can "only support HIV-related needs" and that local AIDS planning councils must be able to make an "explicit" connection between each Ryan White-funded service and its relevance to the care of people living with HIV disease. Activities targeted to people who are not HIV-infected, such as prevention and education activities, are not appropriate for Ryan White support, HRSA says.
City officials said this week that among the reasons for the dramatic $1.8 million cut in federal Ryan White CARE Act funding for Philadelphia region AIDS services was a decision of the Health Resources and Services Administration (HRSA) to reject funding for what the city called "risk reduction/outreach" services provided by organizations supported by the Minority AIDS Project of Philadelphia. They said that HRSA would not fund these projects because they were "education" rather than "direct care" activities. HIV Commission manager Sonya Hunt-Gray said after an emergency Commission meeting earlier this week that since HRSA objected to using Ryan White funding for the risk reduction activity, the projects should simply be terminated.
Elimination of the projects would effect crisis intervention case managers and intervention specialists at about 23 organizations, including Asociacion de Puertorriquenos en Marcha (APM), Chester AIDS Coalition, Committee for a Better North Philadelphia, Ecumenical Information AIDS Resource Center (EIARC), Gay and Lesbian Latino AIDS Initiative (GALAEI), Health Federation of Philadelphia (several health centers), Korean Community Development Center, La Comunidad Hispana, Neighborhood United Against Drugs, One Day At A Time, Parents Against Drugs, Philadelphia Health Management Corporation, Southwest Philadelphia FACT Center, Spectrum Health Services, Unity, Inc., and We The People Living with AIDS/HIV of the Delaware Valley.
Almost $870,000 of Ryan White funding was spent last year on these activities.
"To describe the activities of the risk reduction intervention specialists supported by MAPP as 'prevention education' is simply ludicrous," Wright said. "These staff are engaged in the business of identifying people living with HIV and AIDS and directly linking them to critically needed health and social services. Their activities expand and enhance the AIDS case management system in a way that most of the more established AIDS service organizations are unable to do. They reach people nobody else is able to, or sometimes even wants to, reach.
"It's been clear since these programs were first funded that they were a critical element of the HIV/AIDS case management system, yet the supplemental application describes them as if they were purely educational activities inappropriate for CARE act dollars."
Joe Cronauer, executive director of We The People, noted that the risk reduction intervention program supports the part-time employment of close to 50 people with HIV/AIDS at We The People who "provide direct services to other people living with HIV/AIDS that nobody else ever seems to reach."
"In March alone we helped over 200 people with AIDS obtain over 600 distinct services through our Positive Voices project," which would be eliminated if the Ryan White funding was cut off, Cronauer said. "The whole concept is that by helping people get the services they need is that you keep HIV+ people alive, and you reduce their risk of re-infection and of infecting others. If that's not a 'direct care' concept I don't know what is."
The HRSA letter -- which asks for feedback by April 5th before final rules are adopted by HRSA -- was delivered to the Philadelphia health department but has been withheld from the members of the regional Ryan White Title I planning council, the Philadelphia HIV/AIDS Commission. AIDS Activities Coordinating Office director Jesse Milan has discussed the letter with a few AIDS service providers and consumers, but has not released it to the 40-member HIV Commission even though HRSA has called for comments on the proposals by the end of next week.
Family Planning Council director Dorothy Mann -- whose agency is directly supported by Ryan White CARE Act funds through Title IIIb -- did manage to obtain a copy of the HRSA letter from other sources and shared it with other AIDS activists and agency officials.
The city's application for competitive Ryan White CARE Act supplemental funds, prepared by controversial AACO policy manager Jennifer Kolker, changes the name of the "risk reduction intervention" activity described in the Ryan White Regional AIDS Services plan to "Other Support Services-Outreach Risk Reduction." Rather than describing how risk reduction intervention specialists link people with HIV to care services, the application says that they "assess risk for HIV infection, provide information, and assistance in obtaining counseling, testing and related services."
Kolker has been severely criticized by minority AIDS advocates and people with HIV, especially HIV+ women, for insensitivity to their concerns. As an employee of the Philadelphia AIDS Consortium in 1993, Kolker attempted to remove most references to people of color and services targeted to them from the first consensus regional AIDS plan, written primarily by former We The People executive director David Fair, Pierre DeRagon of COMHAR, and health department physician Esther Chernak. When her changes to the plan were made known to the TPAC board of directors, then-TPAC executive director Jim Littrell ordered that the deleted sections be restored to the plan document.
Fair, a vocal critic of Kolker since her days at TPAC, said this week that the description by Kolker of the risk reduction intervention projects as educational outreach activities "is consistent with years of efforts by Jennifer to downgrade the programs of minority-led agencies and minimize their importance and value. Jennifer is not a racist; she simply has no understanding of the realities facing poor people, people with AIDS or people of color. Entrusting her with the responsibility of describing the concerns of these communities to federal officials, or anyone else, is totally absurd."
"Jennifer Kolker fought against the establishment of these projects when she worked as TPAC's planning manager," Fair, a former board officer of TPAC, told Alive & Kicking! "This year she was finally given a free hand to totally misrepresent what they do in the supplemental application, with the result that we've lost hundreds of thousands of dollars, and put at risk the frontline AIDS service system for the most disenfranchised and needy people with HIV in the region."
Fair noted that unlike in previous years, the supplemental application prepared by Kolker was not reviewed by others outside the health department prior to its submission to HRSA. "This is not the first time that Jennifer has tried to misrepresent the importance of these services," he said, "but it is the first time that the rest of us were not allowed to suggest improvements to the document before it went in" to HRSA.
While the then-newly-formed HIV Commission was asked to formally approve the application in late last year, the group was not given the opportunity to review the document prior to being asked to act. The Commission was told by AACO and Commission staff at the time that the supplemental application simply re-stated previous year activities and programs, according to several Commission members, and that there were no major changes from the previous year's application.
The regional AIDS services plan, on which the supplemental application is supposed to be based, describes "risk reduction/intervention specialists" as "staff who combine HIV risk reduction education with a system of referrals to HIV/AIDS services and other services such individuals may need. This project ... is a demonstration project which seeks to demonstrate the need for less formal case management strategies in meeting the early needs of poor and non-white people infected with HIV."
No reference to this language, which clarifies the connection of the activity to the kind of direct care appropriate for Ryan White funding, was made in Kolker's application.
In addition to clarifying rules about what services are definable as "direct care" services, the HRSA proposal also calls for eliminating CARE Act support for emergency financial assistance for housing, burials, mortgages and property taxes, etc; substance abuse and residential detoxification services; and vocational and employment training.
Members of ACT UP/Philadelphia, We The People and other organizations held several demonstrations in Harrisburg prior to the vote to dramatize the impact of the Ridge cuts.
In addition to forcing single people considered "able-bodied" from Medicaid coverage, the Ridge plan also tightened eligibility for coverage for disabled people and eliminated the "spend-down" provision, which allows low-income people who are working or covered by private disability plans to obtain Medical Assistance coverage during periods when their medical expenses make them impoverished.
Ridge said that the cuts were necessary in order to prevent a $249 million deficit in the fiscal year 1997 state budget. The Ridge budget also calls for over $60 millions in tax cuts for Pennsylvania industry, while increasing the tax on gasoline for average consumers.
Because of the House rejection of the Ridge plan, lawmakers are currently working on other ways to eliminate the projected deficit from the state budget proposal.
In a related matter, plans are proceeding for the implementation of the HealthChoices plan, which will eliminate general Medicaid coverage in the Philadelphia area and require Medicaid recipients to join Medicaid managed care plans. Representatives of people living with HIV/AIDS and several AIDS organizations have participated in public hearings in Philadelphia, Norristown and Harrisburg over the past few weeks, seeking to obtain guarantees that the managed care networks -- which aim to reduce the costs of medical care by rationing health services more cost-effectively -- will not deny care to people with HIV/AIDS because of lack of qualified providers or the relatively high expense of AIDS care. [See fastfax #65]
A delegation from ACT UP/Philadelphia met recently with state welfare secretary Feather Houston to discuss the group's proposal that the state require HMOs to follow a formal standard of care for people with AIDS and assure that a sufficient number of AIDS specialists be available in each plan. ACT UP and other groups have also requested that people with HIV/AIDS be allowed to select infectious disease specialists as their primary care physicians, rather than being forced to seek a referral to the specialists through a general practitioner, as most HMOs require.
ACT UP representatives also discussed mechanisms to assure that the state's Special Pharmaceutical Benefits Program, which faces a 30% cut in the Ridge budget, will still be able to meet the growing demand for AIDS drugs, especially in light of the advent of protease inhibitors. They said that the meeting with Houston was "promising," although no formal commitments have yet been obtained.
ACT UP is sponsoring another demonstration to protest the Ridge proposals at Philadelphia's state office building, Broad and Spring Garden Streets, at 12 noon on Wednesday, April 10th. For more information, call 215-731-1844.
NEW YORK (AP) -- People who manage to avoid infection with HIV despite repeated exposure might be protected by certain blood cells that actively resist HIV, a study suggests.
HIV normally infects so-called CD4 blood cells readily. But CD4 cells from people who avoided infection were found to be unusually resistant, perhaps through overproduction of anti-viral chemicals.
A second study found that in people who are infected, certain immune system genes may strongly affect how long they can go without developing AIDS.
The studies, in the April issue of the journal Nature Medicine, may someday lead to new ways to prevent infection and help in deciding how and when to treat infected people, researchers said.
Scientists found that CD4 cells from people who have avoided HIV infection despite repeated exposure required about 200 times the normal dose of HIV to become infected in the laboratory, said researcher William A. Paxton.
Studies of the most resistant cells found they were pumping out about 10 times the normal levels of substances called chemokines that are known to quash HIV's reproduction in the test tube.
The chemokines may be protecting the cells and the people the cells came from, said Paxton, of the Aaron Diamond Research Center and New York University School of Medicine.
But a researcher unconnected with the study, Dr. Neil Simonsen of the University of Manitoba in Winnepeg, said his work with Kenyan prostitutes who have avoided HIV infection despite very high risk did not find their CD4 cells to be particularly resistant. He said he doubts CD4 cells play a role in infection-resistant people.
Paxton's work involved 25 people with no sign of HIV infection despite having repeated homosexual or heterosexual sex with infected people.
While their CD4 cells could not resist infection completely, even a partial resistance could make a big difference in a person's getting infected because the HIV dose from a sex act is low, Paxton said.
Besides CD4 cells, HIV can infect cells lining the rectum or vagina, Paxton said. But he theorized that if the virus cannot then proceed to infect CD4 cells, the infection may remain localized and get wiped out by the immune system.
Simonsen said immune system cells other than CD4 might be responsible for making some people unusually resistant to HIV infection.
The study on immune system genes is reported by Dr. Richard Kaslow of the University of Alabama at Birmingham and colleagues elsewhere. They identified seven gene variants or
variant combinations that appeared to promote longer lag times between infection and AIDS and
13 that seemed to shorten the interval.
Men with the most favorable overall genetic profiles had lag times about seven years longer than men with the least favorable profiles.
In the general population, half of infected adults develop AIDS within nine or 10 years of
infection.
If the findings are confirmed, such genetic profiles might eventually help doctors choose which infected people to treat early with anti-HIV drugs and how intensely, Kaslow said.
The relationship of the overall genetic profiles to the interval between infection and AIDS was uncovered in a group of 139 men and reinforced by a second study involving 102 men.
Dr. Mark Feinberg, an expert in viruses and immunology at the federal Office of AIDS Research, called the work an important contribution.
The test is intended for use in conjunction with other laboratory markers as an indicator of HIV disease prognosis and as an aid in monitoring the effects of antiretroviral therapy on viral levels in the blood. Use of the test in managing disease in patients will be based on more clinical experience to develop guidelines for physicians.
Recent clinical studies suggest that the viral "load" (or quantity of HIV RNA in the blood) is predictive of the clinical progression of HIV disease. The higher the HIV RNA levels, the greater the risk of disease progression. Amplicor can detect viral loads as low as 400 HIV RNA copies/mL. In addition, the test is a method to identify individuals at highest risk of disease progression -- those with the highest HIV RNA levels -- and to understand whether maintaining low viral loads results in a clinical improvement.
In the past, clinical tests of anti-HIV therapies have relied on indirect markers such as CD4 cell counts to evaluate the drug's effectiveness. More recently, researchers have proposed HIV RNA as an acceptable marker for the activity of antiretroviral therapy in reducing viral load. Clinical trials of the protease inhibitors -- the first new class of HIV/AIDS therapeutics to be introduced since 1987 -- incorporated quantitative HIV RNA testing using PCR along with CD4 cell counts to evaluate efficacy. The FDA accelerated approval of protease inhibitors has in part been based on Amplicor determinations of viral load obtained during these trials.
Prior to the development of Amplicor, there was no way to study the effects of very low viral loads, since other standardized tests were unable to detect levels lower than 10,000 copies per mL. Scott Hammer, MD, AIDS clinical trial investigator and Associate Professor at Deaconess Hospital and Harvard Medical School in Boston, stated, "Many of the newer antiretroviral therapies create a dramatic drop in viral load -- and it's important for us to monitor viral load with as much sensitivity as possible.
Monitoring HIV viremia is vitally important now that new anti-HIV therapies are becoming available, and PCR has shown potential as a powerful prognostic tool.
Over 20 Philadelphians attended the conference, most through scholarships awarded by the case management coordination project of the AIDS Activities Coordinating Office.
Dr. Essex, chairman of the Harvard AIDS Institute, says the world is currently fighting two very different types of HIV. HIV-1B, which is dominant throughout the U. S. and Europe, has affected 1.5 to 2 million people. Th prevalence of this strain is plateauing or even decreasing in some communities.
HIV-1B is transmitted through IV drug use, blood products and sexual intercourse.
The second viral category consists of the HIV-1C, -E, -D and -A serotypes. These strains, especially HIV-1C, (which triggered the heterosexual epidemic in India,) and HIV-E, (which is prevalent in Thai women), are currently running rampant throughout Southeast Asia and Africa. Between 20 and 25 million people are believed to be infected with one of these strains, and the numbers are increasing, Dr. Essex said.
Dr. Essex says these non-B strains are transmitted primarily through vaginal intercourse, and thus threaten a much larger percentage of the world's population. "If these other HIV-1 serotypes take hold in the U. S. or western Europe, a heterosexual epidemic of significantly greater magnitude can be anticipated," Dr. Essex warned. He added that cases of the HIV-1E strain have already been reported in San Diego and Toronto.
Conference reports emphasize importance of avoiding stress
The Fourth International Congress of Behavioral Medicine, held in Washington, D. C., heard a report that a person's personality type affects his or her risk of cardiovascular disease, and that chronic arguing weakens the immune system.
Persons who exhibit "aggressive responding" are at high risk of cardiovascular disease, Dr. Tilmer Engebretson of Ohio State told meeting conferees. Dr. Engebretson conducted thallium-201 exercise testing in 39 men and women with no prior history of myocardial infarction who were undergoing evaluations for heart disease. He found that "aggressive responders" were more likely to experience exercise-induced ischemia.
"Aggressive responding may be a behavioral marker that could provide early identification of people who are at risk of heart disease but who don't yet have damage to the heart," Dr. Engebretson said.
Dr. Margaret A. Chesney of UCSF told conferees that results of the San Francisco Men's Health Study show that patients with HIV infection who have a depressive affect have a two-fold greater mortality rate than their counterparts with a more positive outlook.
Women with breast cancer who are taught how to cope with stress have stronger immune systems than women with breast cancer who don't manage stress well, Dr. Barbara L. Anderson of Ohio State told the Congress. Dr. Anderson's group randomized study subjects to either behavioral intervention or to no intervention. Women who underwent the 18-week course in relaxation, stress reduction and coping strategies had increases in natural killer cells levels while women who received no intervention had no change in the numbers of natural killer cells.
HIV life cycle more rapid than previously reported
Dr. David Ho of the Aaron Diamond Research Center in New York and colleagues have used a mathematical model to determine that the average rate of HIV-1 replication is greater than previously estimated. And Dr. Ho suspects this may have therapeutic implications.
Dr. Ho's team measured blood plasma concentrations of HIV in five patients following treatment with ritonavir. The researchers then estimated the average in vivo virion clearance rate, the infected cell life-span and the viral generation time.
Dr. Ho reports in the journal Science that:
- the estimated daily production of HIV-1 is much greater than previously estimated.
- the average life-span of HIV-1 in vivo is 1.2 days.
- the average time for a virion to infect and kill a cell, and then generate new viral particles is 2.6 days.
These results suggest that antiretroviral monotherapies currently available cannot keep up with rapid HIV mutation. "An effective antiviral agent should detectably lower the viral load in plasma after only a few days of treatment," according to Dr Ho. He adds that "...the "raging fire" of active HIV-1 replication could be put out by potent antiretroviral agents in two to three weeks, However, the dynamics of other viral compartments must also be understood... In particular, we must determine the decay rate of long-lived, virus-producing populations of cells such as tissue macrophages, as well as the activation rate of cells latently carrying infectious proviruses."
FDA: more patients to try hyperthermia
The Food and Drug Administration (FDA) will allow IDT Inc. to add 60 people with AIDS to its trial of an experimental treatment in which patients' blood is scalded in an attempt to kill HIV.
The blood is drained, heated to 114 degrees, and returned to the patient's body. IDT said the expanded trial should provide enough data to seek FDA approval to market the treatment. The FDA warned that the treatment has not been proven to help people with AIDS, although early trials did demonstrate that the treatment did not cause brain damage or other harm. The therapy is based on the idea that the heat will kill some of the virus, giving the patient's immune system a chance to build up a defense. In 1990, the first U.S. attempt at the therapy created a scandal when it was revealed that a patient who was reportedly cured had never been infected. Three years later, the FDA gave the company permission to test the method on six patients, and later allowed a trial of 20 more. None of the patients in the group whose temperatures reached 108 degrees have since suffered any AIDS-related infections, though two patients who did not receive the treatment became ill, as did two whose temperatures did not rise above 104 degrees.