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 the Boston Buyers Club and the Philadelphia Inquirer.
Rendell calls for support for "inner city" health care
City budget reduces AIDS funding by 224G
MAPP faulted for motion's defeat
Roche says no to Costa Rican PWAs
Rendell calls for support for "inner city" health care
While Philadelphia area AIDS planners debate the importance of targeting AIDS funding to low-income and minority communities, Philadelphia Mayor Ed Rendell this week called for increased effort to respond to the health crisis facing those communities as a result of federal budget cuts.
According to the Philadelphia Inquirer, Rendell, attending a conference of the American College of Physicians in Philadelphia, endorsed a policy paper issued by the group which said that poor city-dwellers were paying an "urban health penalty" that causes African Americans to die an average of six years sooner than whites and suffer more than one-third more infectious diseases.
A recent city health department report indicated that three times as many African Americans as whites have died from AIDS since 1995, and that rates of death are declining three times more rapidly among African Americans than among whites. An AIDS housing needs assessment, to be issued soon by the Philadelphia Office of Housing and Community Development, also indicated that about 44% of Philadelphia-area residents living with HIV/AIDS had been homeless at least once in the past year, and that 54% were living on annual incomes of $6,000 or less.
Rendell blamed Pennsylvania Governor Tom Ridge for worsening the health crisis of the poor, saying that the state's reductions in Medical Assistance funding were worsening health care for the poor and were "penny-wise and pound-foolish." Most Medicaid funding cuts are either passed on to private insurers or result in reducing health levels, leading to more use of health services, advocates say.
Rendell told the group that he was aware of at least three community health centers in low-income neighborhoods in the city which would close if there are further cutbacks.
Most of the funding reductions were in the area of HIV prevention and education services, including HIV counseling and testing. The funding reduction is likely to be made up by shifting costs for the affected programs to the federal grant which the city receives from the U.S. Centers for Disease Control.
The decrease in using city funding for AIDS services continues a pattern followed by the Rendell Administration since 1992, when the health department began cutting the use of city tax dollars for AIDS services as new federal funding became available.
AACO's budget for community-based services in the new fiscal year will total $3.9 million, down over $1 million from its 1991 level.
Over $575,000 of the funding available for next year was not formally allocated to specific services or agencies in budget documents presented to City Council.
According to those documents, 20% of city funding for community services supports HIV prevention programs, primarily through the Greater Philadelphia Urban Affairs Coalition, which re-distributes it to small neighborhood groups. Twelve percent of the funding goes to HIV counseling and testing services at Philadelphia Community Health Alternatives, BEBASHI, and Congreso de Latinos Unidos, and 3% for the Community AIDS Hotline operated by CHOICE. Eight percent of the funds support the city's AIDS surveillance effort, which records the names and other data on those formally diagnosed with AIDS.
About 33% of city funding goes directly for services to people living with HIV/AIDS, primarily AIDS case management services, which comprise two-thirds of the direct care funding. All of this funding goes to one agency, ActionAIDS. The remainder of the direct care funding supports homemaker and transportation services provided by Episcopal Community Services and residential drug treatment at Gaudenzia House.
Most of the funding is allocated according to the AIDS service plan developed by AACO in 1987. The city has not made significant changes in the original budget for AACO which was adopted at that time, other than to shift funding to federal funding sources or, in some cases, eliminating entire programs, such as the Rendell Administration's decision to close the Marian Homes group home program in 1993.
Approximately 7.5% of the community-based funding goes to administrative functions, including $118,000 to support the position of director of AACO and $100,000 to the AIDS Information Network for "implementation of policies." Most of AACO's administrative costs, which total over $1 million, are not included in the community services budget presented to City Council.
The motion was made on behalf of the Commission's African American caucus. Most of those who supported the motion, which lost by one vote, are affiliated with the Minority AIDS Project of Philadelphia, which recently released a report which claimed that almost 80% of federal AIDS funding was allocated to organizations with predominately white leadership and staff. Over half of the Commission's members were not present for the important vote.
The critics said that the motion failed, not just on its own merits, but because its advocates at the meeting, which included both Commission members and MAPP representatives, were unable to explain how their plan to "suspend" the allocations process until a plan for building capacity in minority communities was instituted would be implemented. They said that the inability of MAPP representatives to describe how they have utilized over $460,000 in annual funding for minority community capacity building, which has been awarded annually over the past four years, also contributed to the defeat of the motion.
MAPP has been severely criticized by several of its member groups for spending most of the capacity-building money on administering city contracts rather than in creating new services. They have also criticized what they have called the lack of a formal technical assistance plan for use of the technical assistance portion of the funding, which aims to help small neighborhood groups and HIV/AIDS service providers build the internal infrastructure for their organizations.
The motion's sponsors were also criticized for their angry denunciations of those who asked questions of them at the meeting rather than responding to the questions.
"I don't trust mafias no matter what color they are," said one consumer member of the Commission. "It's one thing to talk about expanding services, but it's another thing totally to go after a money grab."
MAPP had previously been criticized for creating what it calls the Philadelphia EMA HIV African American Planning Group (PEHAAP), but failing to involve people living with HIV, sexual minority people, or established African American HIV/AIDS service providers in the process. Concern has also been raised about the involvement of Pennsylvania State Senator Hardy Williams, who chairs the group, in PEHAAP's efforts. Williams has long been associated with a West Philadelphia group called Black Family Services, which has little experience in providing AIDS services and is believed to be seeking funding for its own operations through PEHAAP.
MAPP and PEHAAP have also been criticized for demanding new resources for African American community AIDS efforts but refusing to provide details on how the money would be spent.
Criticism about the debate on the motion was not limited to MAPP, however. Others criticized several white members for implying that the adoption of the motion would have resulted in the closing down of other services already utilized by people living with HIV/AIDS. While the motion's sponsors have stated that they are only talking about new, unallocated funds, they did not respond to this charge at the Commission meeting.
After defeating the motion of the African American Caucus, the Commission later voted to ask the city health department to develop a plan for allocating the funds which takes into account the "general instructions" it included in its AIDS services plan, which include giving priority to organizations which target minority communities, and assuring adequate funding for suburban services and services to women and children.
FDA halts SPV-30 distribution
The federal the Food and Drug Administration has instructed The Health Connection, Ltd., the U.S. distributor of SPV-30, to suspend all sales and distribution of the herbal preparation which is highly popular among people living with HIV/AIDS.
The FDA claims that SPV-30, an all natural preparation of the boxwood evergreen, is a drug and may not be marketed without an approved New Drug Application (NDA). Under the
advice of counsel, The Health Connection, Ltd., is complying with this order. Limited quantities of SPV-30 remain available through not-for-profit buyers' clubs and organizations.
SPV-30 was introduced into the United States in late 1994 by David Stokes, a 34 year old HIV positive gay male on disability from his professional career in consulting. Stokes was searching for alternative, nontoxic, immune-enhancing therapies when Dr. Beth Mestman, a friend and chiropractor from New York, told him about a clinical trial underway in Europe on a promising herbal preparation from the boxwood evergreen, known as SPV-30. Stokes contacted the manufacturer, Arkopharma, to find out more about the product and how to gain access to it.
Stokes learned that SPV-30 showed promising results for HIV positive individuals in a Phase I study in France in 1992 and that a Phase II trial was being conducted in France with Dr. Luc Montagnier as the scientific advisor and chief virologist. Montagnier is widely credited with the "discovery" of the connection between HIV and AIDS.
In vitro (test tube) studies in France indicated that the boxwood evergreen preparation had many alkaloids that demonstrated strong antiretroviral activity. In vivo (in humans),
preliminary results indicated that SPV-30 was effective against HIV with no apparent toxicities or side effects. As an all natural, nutritional and dietary supplement, SPV-30 was imported into the U.S. under the FDA's Generally Regarded as Safe (GRAS) guidelines.
Stokes convinced Arkopharma to make SPV-30 available for free to 400 individuals for six months in the United States. Stokes explained to Arkopharma that due to widespread skepticism regarding the efficacy of natural compounds in fighting HIV, the only way to create an awareness of the product in this country was to provide it free for a large number of individuals nationwide to try it for themselves.
Because there were no apparent toxicities or side effects, there seemed to be little potential harm if participants added SPV-30 to stable, existing regimens. Montagnier believed that SPV-30 was at least a strong antioxidant and a potential natural antiretroviral compound.
An informal study of SPV-30 began in the spring of 1995 to measure the impact of SPV-30 when added to stable treatment regimens. The only criteria for inclusion in the U.S. informal study was that participants must have been on a stable medical regimen (whether it included pharmaceutical drugs or not) for sixty days prior to baseline blood tests. In exchange for specified laboratory results from a recent blood test and filling out a questionnaire, participants were sent a two month supply of SPV-30. At the end of two months, participants sent in another set of lab results and were sent another two month supply. This was repeated at the end of months four and six. After six months, participants were asked to respond to a five page questionnaire which asked about qualitative factors, such as the impact of SPV-30 on energy level, depression, muscle mass, etc. and the impact on symptoms such as night sweats thrush and fevers. They were also asked to be honest regarding changes in therapies during the study that might have affected their test results. An additional two months of free SPV-30 was supplied for returning the questionnaire.
400 participants were enrolled in the national informal study to study SPV-30 in individuals with HIV. Due to early reports of increased energy by many in the study, Dr. Patricia Salvato in Houston asked Stokes to request additional SPV-30 in order for her to conduct a study with fifty chronic fatigue patients. Arkopharma agreed to supply the additional product.
The final report from the U.S. study, which was conducted prior to the advent of protease inhibitors, indicated that of participants who made no changes to their regimens during the six month study and had been on a stable regimen for at least sixty days prior to adding SPV-30, 63% experienced some decrease in viral load. 37% of participants experienced a decrease of 0.5 log or more (decrease of 0.5 log = 70% reduction).
Participants with viral loads greater than 40,000 at baseline experienced better results than the overall group. 91% of participants on stable antiretroviral therapy experienced some decrease in viral load with 55% experiencing a decrease of at least 0.5 log. This may indicate that those who had become resistant to existing regimens, as evidenced by higher viral loads, achieved a greater benefit from adding SPV-30.
Approximately 44% of all study participants experienced an increase in CD4s from baseline to month six regardless of CD4 level at baseline. Approximately 48% of study participants experienced an increase in CD8s. Many participants reported increased energy and appetite, better memory and concentration, and better overall sense of well being.
One of the prerequisites for the HIV activist community to support the informal study of SPV-30 in the United States was that the product must be made available for purchase at the lowest possible price. Obviously, identifying a promising natural compound is only helpful if the product is available to those interested in using it. Arkopharma had no intention of making the product available for sale in the United States but agreed to sell the product through not-for-profit buyer's clubs and selected pharmacies through a U.S. distributor. The Health Connection, Ltd. was instrumental in supplying SPV-30 for the informal study and to buyer's clubs for resale, as well as providing updated information on the ongoing French and U.S. studies to those interested in the product and the latest research information. The Health Connection, Ltd. did not create data for marketing materials. They provided data and information supplied by Arkopharma, the French and U.S. studies, and the U.S. buyer's clubs .
Many natural compounds are being used by HIV positive individuals as alternative therapies to pharmaceutical drugs and increasingly, as complementary therapies, used in combination with the pharmaceutical drugs to increase the drugs' efficacy, decrease side effects and toxicity, and delay resistance. While no one herb or compound alone may be an effective long term treatment, combinations of natural therapies are proving to be quite effective for many. SPV-30 is just one example of a natural therapy being used by HIV positive individuals.
"This draconian action by the FDA to suspend sales of SPV-30 in the US, could be just the beginning of a crackdown on natural compounds that show promising benefits for the HIV positive community," Stokes said in a statement. "We must not let this happen."
For more information, contact The Boston Buyer's Club at (800) 435-5586 or (617) 266-2223.
Roche says no to Costa Rican PWAs
After two meetings and more than five hours of negotiations, officials of the Swiss pharmaceutical company Roche have refused the request of a group of Costa Rican people with AIDS patients to receive the protease inhibitor Invirase for free.
The group first met with Roche officials in February, at which point a promise was made by the company to study the matter and return for another meeting. In the second meeting, held on March 21st, the officials again indicated that would be unable to provide free or significantly discounted medication.
The patient group is a coalition representing about 200 HIV+ persons and PWAs from various clinics throughout Costa Rica. The group has also been meeting with government officials and representatives from other pharmaceutical companies for the last six months.
Guillermo, one of the Coalition members said, "we feel frustrated because we have spent dozens of hours in 'negotiations' with companies and with our own government, but we have yet to receive one pill."
Government officials have told the group that they are studying various proposals to provide reimburse for AIDS medications, but that any decisions are still months away. In Costa Rica, the only antiviral medication which is provided is AZT, and that is given only to pregnant women.
A group spokesperson indicated that "we know the government bureaucracy moves slowly and that huge costs are involved. But the pharmaceutical company has plenty of money and could make a humanitarian gesture to save lives until the government is able to organize itself and make a decision. It seems incredible that we could talk to the people from Roche for over five hours during two months and that they are unwilling to offer anything concretely as far as medications go. We asked for free medications for 50 patients.
Dr Max Bucher, Director of Roche in Costa Rica, indicated that he does not have the authority to make a decision authorizing free medication. He told the group that 14 patients in Costa Rica are already receiving Invirase free through their physicians.
The Roche product, Invirase, costs about $800 a month in Costa Rica, where the monthly per capita income is only $250. "Nobody here can afford these prices," Guillermo said, even less a person who is already ill and unable to work.
Richard Stern, Pd.D., Health Coordinator of the gay/ lesbian group Triangulo Rosa said, "We understand that pharmaceutical companies must recuperate the costs of the investigations necessary to develop these medications. But we also feel that the prices that they have set are
arbitrary. Why is it necessary to set the same price here in San Jose as in New York or London? Here $250 per month is the average salary. Why not set a more reasonable price in poorer countries, recognizing that the primary goal is that medications should be accessible to people who need them. On a worldwide level, these companies must consider the real cost to produce their product at this moment, which is much lower, and try to make these medications available in order to save lives now. We are not talking about television sets here. We are talking about a tiny pill, that can save thousands of lives, and the actual value of the ingredients in the pill is just a few dollars."
There are currently 1,100 diagnosed cases of AIDS in Costa Rica. 70 percent of these have occurred in the gay community.
To obtain a weekly email version of fastfax, contact with the message: "subscribe".