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Issue #158: January 4, 1998
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 American Journal of Epidemiology, Journal of Infectious Diseases, New York Times, Reuters, San Francisco Chronicle
Ridge seeks $5.4 million increase for SPBP
Clinton asks more funding for ADAP programs in 1999
Breast milk confirmed as source of HIV
High HIV rates found in needle program
ActionAIDS plans January "wellness" series
Ridge seeks $5.4 million increase for SPBP
Pennsylvania Governor Tom Ridge has requested the General Assembly to add $5.4 million to the state's Special Pharmaceutical Benefits Program, which assists low-income and uninsured people with HIV/AIDS in obtaining AIDS medications, according to Philadelphia Sen. Vincent Fumo.Earlier in December, Carol Ranck, HIV/AIDS coordinator for the state Department of Public Welfare (DPW), had told AIDS planning councils throughout the state that the SPBP was projecting a $5 million deficit for this year.
Ridge is proposing using $4.55 million of the state's expected $380 million surplus to finance the deficit. About $950,000 of the increase will come from a special federal grant awarded to Pennsylvania under the federal AIDS Drug Assistance Program.
No other AIDS-related programs are expected to benefit from the state surplus.
The original Ridge budget for this fiscal year contained $10.9 million for SPBP, but that amount was rapidly exhausted because of the growing demand for expensive protease inhibitors among the programs participants. The SPBP budget is supported by $6.3 million in state funds and $4.6 million in federal Ryan White funds. It is estimated that each participant in SPBP uses between $15,000 and $18,000 annually for protease inhibitors alone. Costs for almost 50 other AIDS-related drugs are also supported through the program.
According to Ranck, 2,250 Pennsylvanians with AIDS are participating in SPBP, as well as about 1000 people who obtain Clozaril, a mental health medication. AIDS-related expenditures account for about 80% of the programs costs, according to Ranck.
In her report to the planning councils, Ranck also said that the state is still unwilling to add the two FDA-approved non-nucleoside reverse transcriptase inhibitors (NNRTIs), Viramune and Rescriptor, to the list of approved SPBP drugs because of concern that the additional costs might jeopardize the availability of drugs to "current enrollees" or "necessitat[e] implementation of program restrictions." ACT UP and other AIDS advocates have complained that the state has violated a commitment made several years ago to automatically add new FDA-approved medications to the SPBP formulary. Ranck said that SPBP staff will continue to refer applicants for NNRTIs to patient assistance programs of the pharmaceutical companies who manufacture the drugs (Viramune: 1-800-274-8651; Rescriptor (1-800-711-0807). She said that DPW evaluates its ability to add new drugs to the formulary on a weekly basis, taking into account "clinical factors, protecting current enrollees' access, projected utilization and costs for the particular drug, and available financial resources."
"SBPB is not an entitlement program," Ranck said.
Ranck said that the state hopes to avoid restrictions and waiting lists for SPBP, which have become common in AIDS drug assistance programs in other states. "Weekly and ongoing analysis of the program will enable us to closely monitor the program and make necessary adjustments," she said.
Ranck also noted that DPW covers the costs of protease inhibitors for Medicaid recipients, who because they are insured are not eligible for SPBP, through a special "fee for service" program rather than putting the burden of that cost on the HealthChoices HMOs.
In a related matter, Ranck confirmed that managed care organizations participating in the state's Medicaid program, HealthChoices, receive a monthly "risk-adjustment" of an average $1,030 per member per month for members who have HIV disease. She said that managed care companies can ask for an additional amount if they can show that their plans have a significantly larger proportion of people with HIV/AIDS seeking care than was originally projected in their contracts with HealthChoices. The HealthChoices plan with the highest number of AIDS patients, HealthPartners, has been forced out of Temple University's AIDS program as well as four hospitals in Delaware County, largely because of its difficulty in covering the costs of AIDS-related care.
Clinton asks more funding for ADAP programs in 1999
President Bill Clinton plans to seek more funding for programs that help people infected with HIV pay for the expensive drugs they need, the White House said last week.Spokesman Joe Lockhart confirmed a New York Times story that said Clinton would seek a 35 percent increase in spending for AIDS drug assistance programs which help pay for protease inhibitors.
People infected with HIV are generally unable to obtain these drugs under the federal Medicaid program until they become severely ill, the official said.
But the drugs can slow the progression of the infection, thus preventing disability. According to a recent report from the President's Advisory Council on HIV/AIDS quoted in the Times, "The current Medicaid eligibility criteria are in direct contradiction to the recommended standard of care for the treatment of HIV disease."
Clinton is expected to request $385 million for the drug programs in the fiscal year 1999, up from $285 million this fiscal year and $167 million last year, White House officials said.
The increase in proposed spending for the AIDS drug assistance programs is part of an overall $165 million increase the Clinton administration will propose for the Ryan White Care Act to help treat and care for people with AIDS, they said.
The proposed increase would represent a 14 percent rise in spending for the program that helps provide medical care for people suffering from the disease. That would raise total spending to slightly more than $1.3 billion, officials said.
Meanwhile, California Democrat Nancy Pelosi is stepping up congressional efforts to expand the right of people living with HIV/AIDS to get protease inhibitors earlier in the disease process.
As previously reported in fastfax, eight months after Vice President Al Gore asked for a Medicaid policy change allowing poor people with HIV to get effective new drugs for free, the government has concluded the plan is too costly.
Gore and officials at the Department of Health and Human Services were told in December that the additional cost of the drugs isn't permitted under terms of the federal budget.
They said they haven't given up yet, and will try again to somehow finance the drugs, which cost from $15,000 to $18,000 a year for the average person with HIV.
HHS estimates that some 155,000 poor people with HIV who cannot now buy the newest AIDS drugs would have received them had the Medicaid rules changed. The cost: about $19 million a year. Medicaid already spends about $4 billion a year on AIDS treatment.
HHS officials had been trying to overcome a puzzling catch-22 situation in which the poor are losers: The government does not uniformly pay for the drugs, called protease inhibitors, until poor people on Medicaid have an actual AIDS diagnosis. These drugs, however, have proven their ability to delay illness as well as the cost of catastrophic medical care.
The federal government's own guidelines for treating HIV say that early therapy with new antiviral drugs - before the onset of AIDS symptoms - is extremely effective in slowing the disease's progression and ultimately saves money.
Reaction among AIDS activists to the government's decision has ranged from disbelief to outrage. Rep. Nancy Pelosi, D-San Francisco, has introduced legislation to provide limited benefits, including the recommended drugs, to HIV-infected Medicaid recipients.
"This is a very bad decision," said Pelosi. "If the federal government cannot afford the funding for the new drugs, new therapies, how on Earth are poor people going to be able to afford them?
"We cannot live with the (administration's) decision that it would cost too much money because it would save revenue in the big picture," Pelosi said.
In addition to introducing a bill to fix the catch-22, Pelosi and Minority Leader Richard Gephardt, D-Mo., wrote HHS Secretary Donna Shalala asking her to include the benefit in the president's fiscal year 1999 budget request.
ADAP gives $285 million to states to underwrite the cost of the new drugs. Of that, about $5 million goes to Pennsylvania.
Nationwide, states provide vastly different matching funds for Medicaid and ADAP. Efforts, like Pelosi's legislation, to change policy aim to make the benefits uniform and available in every state.
In Washington, HHS spokesman Victor Zonana said, "We very much want to get drugs to people who need them and can't afford them, and what the specific mechanism might be remains to be seen."
To that, Pelosi retorted: "The need for the drugs does not remain to be seen. It is current and urgent, and that is why I would like to see some faster action on this."
Criticism of the decision not to expand Medicaid's coverage has mounted steadily this month, not only because of concern for the poor but because of the economic benefit of early treatment.
"It's stupid, it's cruel, it makes no sense," said Cleve Jones, co-founder of the Names Project, the display of quilts memorializing people who have died of AIDS.
Last year, Jones personally lobbied President Clinton to increase funding for ADAP. Clinton did not seek additional money, nor did he authorize federal money for needle exchange programs. Jones called these "betrayals," and said experts who sit on the advisory council on AIDS to the president, "if they had any integrity at all, every one of them should resign."
The poor, said Peggy Taylor-Campbell of San Francisco, who is among them and HIV-positive, suffer enough without having their lives "played with" in the debate. She is able to keep symptoms of AIDS at bay with a regimen of three new drugs because Medi-Cal, the California Medicaid program, covers their cost. If she lived in another state, she might have to go without this treatment.
"These new drugs have done people a world of good," said Taylor-Campbell. But "unless you are in a program in which you can get the drugs, you're just out of luck."
At San Francisco General Hospital, doctors have seen a dramatic reduction in expensive AIDS-related infections among patients taking the new drugs, indicating that protease inhibitors actually save health care dollars, said Dr. Paul Volberding, who heads the AIDS program there. One such infection, CMV retinitis, can cause blindness, and typically costs more than $25,000 to treat. The new antiviral drugs now available against HIV have nearly eliminated CMV retinitis in the hospital's AIDS unit.
"It doesn't take very many of those cases prevented to save the cost of the drug therapy," said Volberding.
Breast milk confirmed as source of HIV
In the January issue of The Journal of Infectious Diseases, US and Kenyan researchers provide evidence to confirm that breast milk from HIV-infected mothers contributes to the vertical transmission of HIV-1. Specifically, they found that "[t]he prevalence of cell-free HIV-1 was higher in mature milk (47%) than in colostrum (27%)."Breast milk has been suggested as an important source of vertical HIV transmission, Dr. Paul Lewis of Oregon Health Sciences University in Portland and colleagues said. However, they believe that this is the first study using a highly sensitive PCR assay for viral RNA to detect cell-free HIV-1 in breast milk.
Dr. Lewis' group analyzed samples of breast milk from HIV-positive women in Nairobi. "HIV-1 RNA was detected in 29 (39%) of 75 specimens tested." About half of the 29 specimens contained HIV-1 RNA levels near the limit of detection, and 21% of the samples had more than 900 copies/mL. "The maximum concentration of HIV-1 RNA detected was 8,100 copies/mL."
Overall, ...the prevalence of HIV-1 RNA did not decrease as the milk supply matured." Dr. Lewis' team concludes that transmission risk "...is likely to be related to the quantity of HIV-1 in cell-free breast milk in addition to other factors, such as number of HIV-1-infected cells in breast milk, the presence of antiviral substances in breast milk, and factors determining infant susceptibility."
High HIV rates found in needle program
Participants in a Montreal-based needle exchange program appear to have higher HIV seroconversion rates compared with injection drug users (IDU) who do not participate in the program, according to a report in the December 15th issue of the American Journal of Epidemiology.This is explained, in part, by the program's attraction of "...subpopulations of IDUs with a higher baseline rate of HIV and hepatitis B infections," Dr. Julie Bruneau of the University of Montreal and colleagues said. Despite these higher baseline rates of infection, the Canadian researchers maintain that "..a positive association between [needle-exchange program] attendance and risk of HIV infection..." persists.
Dr. Bruneau's team calculated a baseline HIV prevalence of 10.7% among 1,599 IDUs evaluated between 1988 and 1995. The Montreal group found that the adjusted odds ratio for HIV seroprevalence was 2.2 for IDUs reporting recent needle-exchange program participation. Similarly, in a cohort study, they identified "...89 incident cases of HIV infection with a cumulative probability of HIV seroconversion of 33% for [needle-exchange program] users and 13% for nonusers." Finally, they detected an association between consistent use of needle exchange programs and HIV seroconversion during the follow-up period of a nested case-control study.
HIV risk in all three scenarios was increased among IDUs participating in the needle-exchange program, the Montreal investigators concluded. "Public health authorities have been informed of our findings, and measures have already been implemented...notably, removal of the individual quota on syringe distribution." Dr. Bruneau and her associates believe the findings "...firmly [suggest] that needle-exchange programs should be fine-tuned to local needs..." and that further studies to evaluate this intervention are needed.
In an accompanying editorial, Dr. Peter Lurie, of the University of Michigan in Ann Arbor, takes issue with the authors' conclusions. "Do these results demonstrate that [needle-exchange programs], far from preventing HIV transmission, actually cause an increase in transmission as some [needle-exchange program] opponents have claimed? And do the results mandate the abandonment of HIV prevention policies for IDUs based on the provision of sterile syringes? The simple answer to both of these questions is 'no,'" he writes.
Dr. Lurie cites the authors' own statement that "...this cohort is an observational study and was not designed to study or evaluate [needle-exchange programs]."
Overall, he believes there are three lessons to be learned from this paper. First, it illustrates how research findings can be "...manipulated by politicians." Specifically, Dr. Bruneau's unpublished results had been cited by US Assistant Secretary for Health Dr. Philip R. Lee in his defense of a continued ban on needle-exchange programs in this country. Second, Dr. Lurie asserts that "...if [needle-exchange programs] are attracting the highest risk IDUs, they would seem to be ideal locations to provide and evaluate more intensive risk-reduction interventions." Third, Dr. Lurie feels that rather than limiting the number of syringes for distribution to IDUs, increasing needle exchange would reduce the rate of HIV infection in Montreal.
In a rebuttal, Dr. Bruneau et al. deny that any political pressure was exerted upon them, and that the controversy over needle-exchange programs has been largely confined to the US. They also dismiss the assertion of selection bias. "Despite Lurie's well-founded views on the issue, we have yet to hear a cogent argument that would allay our concerns that [needle-exchange programs] may facilitate formation of new sharing groups gathering isolated IDUs, a scenario that is consistent with our findings."
ACT Program of Action AIDS January 5, 7, 12, 14, 26, 28, 1998 @ 3:00 p.m. - 5:00 p.m."Maintaining Wellness Series 11"
January 1998
Our purpose is to support you in experiencing better emotional, physical and spiritual health in 1998. If you are ready, we will help you to get a "New Attitude!" Come join us in 1998 and give us your suggestions on how we can assist you in having a very
Happy New Year!
"Qi Gong Series" - "Qi Gong: any training or study dealing with Qi (energy) which takes time and effort to develop." How can you have more energy, shake off depression, and decrease some of those aches and pains? Qi Gong! This class is awesome! Try it out! Then tell us how you feel.
Monday, January 5, 12, 19, 26*, @ 6:00 - 8:00 P.M. ( * = see front desk for location)
Reiki Sharing: Come experience a Reiki Treatment!
Reiki is a form of healing energy used to promote wellness. This "laying on of hands" technique will cause deep relaxation, decrease anxiety, pain, and stress. Try it you'll like it.
Thursday, January 8,15,22,29, 1998 @ 6:00 p.m.- 7:30 p.m.
Meditation Practice: You can have more peace of mind, enhance your immune system, and nurture your creative self. Regular daily time outs of meditation and stretching have been proven to provide the above mentioned results.
Tuesday, January, 6, 13, 20, 27, 1998 @ 5:30 - 7:30 p.m.
"Unlimited Power - Tapes #11-15
How much does the way you think impact your life experience? A whole lot! This $200.00 tape series is made available for your listening education free of charge. Relax, Listen and learn. .Anthony Robbins is the best selling author of "Unlimited Power", and other success focused technology.
All workshops are participatory with pre-registration required Good Health = Spiritual, Emotional and Physical Balance
You deserve balance!
These educational forums are for anyone living with HIV or AIDS.
YOU DO NOT HAVE TO BE AN ACTIONAIDS CLIENT .
For more information or to pre-register call Kevin D. Greene, ACT Program Coordinator @(215)981-3330., 1216 Arch Street, 6th Floor, Philadelphia, PA 19107