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Issue #146: October 12, 1997
FASTFAX is available by fax in the 215 and 610 area codes at no cost, by mail anywhere for 20.00 per year, by calling 215-545-6868, and on our web page, http//www.critpath.org/wtp. If you receive duplicate copies by E-mail, or wish to be removed from this mailing list, contact wtp@critpath.org and type the message REMOVE in the message section. Sources for some information in this issue include AIDS Research and Human Retroviruses, Bulletin of Experimental Treatments for AIDS, Journal of the American Medical Association, Reuters, United Press International.
In this issue:
Feds increase pressure for HIV reporting
New HIV test finds infection earlier
AIDS docs seek funding for drug programs
Specialists should provide primary AIDS care: docs
City to re-bid minority funding
Preventive TB treatment not needed by most PWAs
Marijuana use OK for AIDS study
Studies find new approaches to AIDS therapy
Feds increase pressure for HIV reporting
With legislation pending in Congress which would force states and municipalities receiving federal funds to require that those who test positive for HIV infection be reported to local surveillance offices, the U.S. Centers for Disease Control has stepped up its pressure on local health authorities -- including Philadelphia's AIDS Activities Coordinating Office -- to begin planning to legally require reporting of HIV+ people.New Jersey, which includes four counties which are part of the Philadelphia AIDS services region, has required HIV reporting for several years.
In a survey sent by the CDC to all 50 states and many cities, the agency asks local health authorities to begin developing plans for initiating HIV reporting in their communities. The survey also asks when the communities will be ready to require HIV reporting, with indications that they hope all cities and states will implement the new requirement by next summer.
In Philadelphia, only a diagnosis of AIDS is reportable. The number of people who test positive for HIV antibodies is, then, unknown to public health officials and advocates.
To date, city officials have relied on federal estimates of how many HIV+ people there are in the region, which are based on formulas which project levels of HIV infection from the numbers and demographics of those being diagnosed and reported with AIDS.
The city's AIDS surveillance system records the name, address, and medical and personal information on each person diagnosed with AIDS. The reports are submitted, under a requirement of the Philadelphia City Charter, by doctors, clinics, and hospitals, and are sometimes identified by city "surveillance officers" from analysis of hospital records and death certificates filed with the city. AACO, which receives the reports, then codes the identities of those whose diagnosis is reported and submits the data to the CDC.
It was unclear whether the CDC will expect that the full names of HIV+ people be reported under the proposed new rules.
Most local AIDS advocates have traditionally opposed reporting of HIV infection, claiming that the only reason why public officials seek the authority is because it would provide data which would increase the ability of the city to compete for federal and state AIDS funding. They say that benefit is outweighed by the need for confidentiality of HIV test results, citing studies which indicate that almost one in five people being tested for HIV say that they would be less likely to get tested if their name was going to be reported.
Other activists have been critical of the claim that identifying those who test HIV+ to the government would increase their opportunities to obtain medical care. They say that without more resources being allocated to help people newly diagnosed with HIV infection to link to ongoing medical care, little is actually done to make sure people get access to early intervention services. Anna Forbes, a local AIDS activist, wrote in The New York Times in August that data from a Centers for Disease Control and Prevention study indicated that almost 20 percent of high-risk individuals cite fear of giving their name as a reason to avoid testing.
In the Philadelphia region, most of those seeking testing at publicly funded sites are required to give their name to the test counselor, but the information is not transmitted to other public agencies. Some anonymous test sites remain open in the Philadelphia area, and it was unclear whether the new reporting efforts of the CDC would allow for continuing anonymous testing. Most funding for public HIV counseling and testing programs is provided by the CDC.
Forbes also challenged the assumption that reporting names will make it easier to ensure that HIV-positive persons receive follow up treatment. The same CDC study, she said, found that people with HIV got into care as quickly at locations where names were not used as at those facilities where names were given.
Forbes asserted that code reporting -- that is, assigning a "unique" identifier to the person instead of their name -- is a more effective measure for keeping track of cases. Forbes notes that Maryland, which follows trends in HIV infection, has attained 97 percent completeness in reporting through this procedure.
Philadelphia and Pennsylvania officials have refused previous attempts to pilot code reporting projects to see if they would be effective in this region. A proposal to test a code reporting program submitted by Forbes to the city several years ago was rejected, as was a similar proposal submitted by We The People to the American Foundation for AIDS Research in 1994. A city proposal to require name reporting of low CD4 counts by area laboratories was suspended by health commissioner Estelle Richman in 1995 after community protests, who also rejected proposals that the city test a coding system for the reports.
Recent press reports have indicated, however, that as AIDS treatment advances continue, the privacy concerns that have long set HIV-infection apart from other infectious diseases such as tuberculosis, gonorrhea, and syphilis have begun to fade.
Elected officials, health professionals and a growing number of advocates for people with AIDS are changing their positions regarding mandatory testing and notification that have long been used by medical practitioners in slowing the spread of other infectious diseases.
New drug therapies have made early HIV detection and treatment more beneficial than ever before, and public officials are giving higher priority to utilizing their AIDS resources to help people living with HIV obtain primary medical care. For those reasons, AIDS specialists and public advocates that fought tooth and nail in defense of privacy rights are now coming around to see that, all things considered, such rights may no longer be in the patient's best interest.
The AIDS Action Council, which represents more than 1,400 AIDS service agencies across the country, is in the process of reviewing its opposition to states which demand all positive HIV results be forwarded to public health departments.
"It's time to recognize that the earth has shifted underneath all of us fighting the AIDS epidemic," the Council's executive director, Dan Zingale, said.
In all, 28 states now have mandatory HIV reporting. However, that these states account for only 24 percent of the cases reported to the CDC. Of the 10 with the highest number of reported cases, only New Jersey and Louisiana have adopted HIV reporting.
One of the principal forces behind the new shift in thinking has been the CDC, which has become much more vocal in advocating nationwide mandatory HIV reporting in the last six months. Dr. John Ward, who heads the CDC's HIV-AIDS surveillance branch, said "We are in an era where there is more of a compelling need for HIV surveillance than 18 months ago."
Planning vaccine research and targeting scarce resources -- be they preventive, service-oriented, or medical -- to new areas where infections are on the rise are just some of the benefits mandatory reporting would advance, he said.
Cleve Jones, founder of the NAMES Project AIDS Memorial Quilt, told the Times, "Everything is changing so rapidly right now that most of us are in a position of having to re-evaluate everything we held to be gospel for many years."
New HIV test finds infection earlier
An Israeli company received a U.S. patent for a test that enables HIV antibodies to be detected sooner after infection than conventional methods.Officials at the Rehovot-based Shiloov Medical Technologies Ltd. said the HIV ShiloovTube uses a "patented mix of biochemicals" to accelerate the production of antibodies to HIV in blood specimens, which makes it possible to detect antibodies within 1-to-2 weeks after infection using conventional HIV antibody tests. Normally, it can take up to 6 months for HIV seroconversion to occur, according to Tamar Jehuda-Cohen of Shiloov.
The HIV ShiloovTube can provide earlier diagnosis of HIV infection and can be used by blood banks to screen for HIV, continued Jehuda-Cohen, who also developed the technology. "We believe that the HIV ShiloovTube...will have a dramatic impact on the safety of the world's blood supply."
Clinical trials of the HIV ShiloovTube are scheduled to begin in the US by the end of 1997, and the company plans to apply for final approval by the end of next year.
AIDS docs seek funding for drug programs
The International Association of Physicians in AIDS Care (IAPAC) is calling for congressional reform of the AIDS Drug Assistance Program (ADAP), the $167 million federal program that is today struggling to provide states and local governments with funds to make life-saving and life- extending AIDS drugs available to low-income people with HIV/AIDS.A proposal detailing the reforms will be announced at IAPAC's International Conference on Healthcare Resource Allocation for AIDS and Other Life-Threatening Illnesses on November 10th in Washington.
The IAPAC proposal will lay out four basic reforms:
--Take ADAP out of Title II of the Ryan White CARE Act and establish it as a stand-alone title.
--Mandate federal guidelines for the ADAP formulary to guarantee all eligible recipients access to all appropriate, FDA-approved drugs consistent with established Public Health Service clinical treatment guidelines. Because of budget shortfalls, many states have had to drop certain drugs from their state ADAP formularies. Pennsylvania, which led the nation in its early approval for including protease inhibitors in its ADAP formulary, has yet to include the newest protease inhibitor, Viramune, among drugs available through its Special Pharmaceuticals Benefits Program, the Pennsylvania ADAP.
--Require every state to match federal ADAP funds. Currently, only a few states, including Pennsylvania, provide a matching contribution.
The proposed reforms are based on a report titled, "Ethical Considerations in Providing Life Saving and Life Extending Drugs to the Medically Indigent in the United States, A Country Without National Healthcare," by John Collins Harvey, MD, Ph.D., Professor of Medicine Emeritus, of Georgetown University Medical Center. Harvey's presentations will be featured in the November issue of the Journal of the International Association of Physicians in AIDS Care.
The proposal could spark strong opposition from some because it could generate the reallocation of ADAP funds. Whigham expects strong opposition to the proposal requiring states to provide matching funds to be eligible for federal ADAP funding. According to Whigham, "The opposition will not be over the equity of the proposal for people with HIV/AIDS, it will be over control of federal monies."
Specialists should provide primary AIDS care: docs
The concept of AIDS as a primary care disease needs to be reexamined, according to New York-based researchers.Based on the most recent developments, it appears that the time of the "HIV specialist" has arrived, say Drs. Abigail Zuger of Albert Einstein College of Medicine and Victoria L. Sharp of St. Luke's-Roosevelt.
In the current issue of The Journal of the American Medical Association, they point out that there now is "...a new appreciation of the potential and limitations of antiretroviral therapy." Advances in the area of HIV pathogenesis, along with the increased "...penetration of managed care into clinical medicine" have also changed the treatment scenario.
The original primary care paradigm at the beginning of the decade called for the monitoring of asymptomatic HIV-positive patients. However, it is becoming apparent that early treatment intervention is warranted for these patients, the authors point out. More and more HIV drugs are becoming available through research protocols and expanded access programs, and some patients are more informed about state-of-the-art treatments than their physicians.
Recent studies have also found that patients treated by AIDS experts have "significantly prolonged survival times" compared with patients treated by physicians with less experience.
Although all physicians should know the basics of HIV prevention and diagnosis, Drs. Zuger and Sharp say "...full care is necessarily the realm of expert physicians with ongoing clinical expertise." They believe that "the medical complexities of [patients with HIV infection] should not be trivialized by well-meaning efforts to mainstream them."
In a second editorial, which appears in the same issue of the Journal, Dr. Charles E Lewis of the University of California in Los Angeles agrees that HIV-infected patients are probably better off with clinicians with have extensive experience. However, the government's recent "Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents" do not provide "...recommendations for the means to accomplish the suggested pattern of referral between 'experts' and 'nonexperts.'"
One possible benefit of using a primary care physician is that there may be "...a more extensive and ongoing relationship between physicians and patients and between physicians and patients' families and significant others." Dr. Lewis also points out that "...the reality is that a variety of barriers such as geography, economics and professional pride may thwart the intention of policymakers."
City to re-bid minority funding
AACO officials have informed the Minority AIDS Project of Philadelphia (MAPP) that over $400,000 which the organization has received every year since 1994 to "build capacity" of minority AIDS organizations in the Philadelphia region will be re-bid next spring, when the city will be re-allocating a portion of the federal funding it receives under Title I of the Ryan White CARE Act.The city's decision comes after months of controversy surrounding a decision by health commissioner Estelle Richman to shift $100,000 to the Philadelphia EMA HIV African American Planning Group (PEHAAP), as well as add another $100,000 for PEHAAP to manage city AIDS funding for African American and Latino organizations providing AIDS services. The PEHAAP decision was widely criticized by people with HIV/AIDS and leaders of minority AIDS organizations, who said that PEHAAP was not competent to develop AIDS services and had only been created by West Philadelphia state senator Hardy Williams as a way to get control of city AIDS funding.
After heated debate, Richman suspended the PEHAAP allocation.
Nonetheless, African American members of the Philadelphia HIV Commission, which advises the city on AIDS allocations, pushed for the Commission to oppose any funding of PEHAAP last summer. In a letter to the Commission co-chairs, Richman noted that the Commission is not permitted to influence the city on specific AIDS grants, but only on general priorities for the funding. She said, however, that she agreed that funding for AIDS planning and capacity-building activities should be made available only through a competitive bidding process, and that she would implement such a process for the funding currently allocated to MAPP by next spring. PEHAAP, as well as any other agency, can submit a proposal for the funds, she said, although final decisions on how the money is allocated will be made by the Health Department.
MAPP has been criticized in recent years for utilizing the capacity-building program to pay high salaries to its top three administrators -- whose salaries and benefits total almost $200,000 -- and for shifting its focus from creating and enhancing minority services to one of processing city contracts and acting as fiscal management for some agencies. While MAPP continues to be responsible for providing most technical assistance and program development services to minority agencies in the city, less than 25% of the capacity building funding is made available for technical assistance activities.
MAPP has also been criticized for making decisions on priorities for its funding without consulting with people living with HIV/AIDS or the minority AIDS service organizations which are nominal members of MAPP. The organization no longer has an active steering committee, and most decisions are made by staff. Two African American organizations have pulled their funding out of MAPP, opting for direct contracts with the city, and at least five others are actively considering doing so when their contracts come up for renewal next spring.
Preventive TB treatment not needed by most PWAs
New findings suggest that preventive treatment for tuberculosis (TB) is not necessary for people with HIV who have negative TB skin test results due to poor immune response, according to a recent article in the Bulletin of Experimental Treatments for AIDS, published by the San Francisco AIDS Foundation.A study conducted by the Terry Beirn Community Programs for Clinical Research on AIDS compared 2 groups of HIV positive individuals at high risk for TB; high-risk individuals include homeless persons and injection drug users.
One group received preventive therapy with the anti-TB drug isoniazid, while the other group received placebo. The number of persons developing active TB disease did not differ significantly between the 2 groups. According to Anthony Fauci, MD, of NIAID, "this study suggests we can make more effective use of TB prevention resources by focusing on HIV-infected persons with known TB infections or who have close contact with another individual with active TB."
For those HIV positive persons who have been exposed to Mycobacterium tuberculosis, new research from Spain published in the Archives of Internal Medicine indicates that long-term (12 month) isoniazid prophylaxis is effective in preventing active TB disease and leads to increased survival in people with HIV.
Marijuana use OK for AIDS study
The National Institutes of Health has allowed a group of doctors and scientists at University of California, San Francisco to study the effects of marijuana on HIV-infected patients.The approval comes after several attempts by researchers to secure funding and the government-supplied marijuana required for the study.
Researchers will compare patients who smoke marijuana or take marijuana pills with a control group that takes neither to monitor the interaction between pot and the drugs HIV patients take to bolster their immune systems.
The participants will be taking one of the most commonly prescribed protease inhibitors for the HIV infection, which are metabolized in the liver.
Smoking marijuana or taking Marinol could change the concentration of the protease inhibitor in the blood, either creating a highly toxic level or too low a level and making the protease inhibitor ineffective.
Researchers say they believe there are a number of HIV-infected patients in the Bay area who already use marijuana, so it is "important that we get some answers about the safety of using THC," the active ingredient in marijuana.
The NIH will contribute $1 million to the two-year study, which will begin at the end of 1997 and study 63 patients during a 21-day trial at the San Francisco General Hospital.
Studies find new approaches to AIDS therapy
Two studies published last month found possible new approaches to battling HIV, and also shed more light on the insidious ways the virus attacks the immune system.Both centered on cytokines -- the immune system signaling chemicals that HIV depends on to get into the immune system cells that it infects.
Researchers have found that HIV needs a number of different receptors, or chemical doorways, to get into cells. Many of the receptors are the same ones that cytokines use.
In a study published in the journal Nature Medicine, David Weiner and colleagues at the University of Pennsylvania medical center said HIV may suppress the production of cytokines in its victims, thus killing off its enemies before they are even born and freeing up the receptors for its own use.
They found that HIV produces a protein known as Vpr, which blocks production of cytokines in the cells it infects.
"In the test tube, Vpr suppresses production of the cytokines needed to fight any infection, bacterial or viral," Weiner said in a statement.
Vpr also prevents the infected cells from committing suicide in a process known as apoptosis -- the programmed cell death that is meant to protect the body from just such infections and from cancer.
"So those cells can stay alive to make more virus. And then it kills the uninfected cells that would otherwise be involved in providing immune protection," Weiner said.
But Weiner's group said they may have found a way to block this process. They noted that certain drugs act in the same way as Vpr and tried out the steroid RU-486 -- sold as an abortion drug in Europe.
"When we added RU-486 to our cell cultures, it markedly reversed many of the effects of Vpr," said Valpandi Ayyavoo, who led the study.
"These results suggest that steroids should be considered for development as potential HIV therapies."
Si-Yi Chen, a cancer biologist at the Bowman Gray School of Medicine in Winston-Salem and colleagues took a completely different approach. They said they may have found a way to stop HIV from ever infecting immune cells in the first place.
Many teams have tried to find a way to block the receptors that both cytokines and HIV use to get into cells -- but efforts to do so have so far failed.
Chen's group tried to model people who have a genetic mutation that seems to make them naturally immune to HIV infection.
They homed in on the CXCR-4 receptor -- one of several receptors used by both the AIDS virus and cytokines.
They genetically altered the immune system cells so that they could produce the CXCR-4 receptor, but could never get it to their surface -- so then HIV could not find it to latch onto.
They used an intrakine -- an internal cell molecule that attaches itself to the CXCR-4 molecule and held it inside the cell.
"The genetically modified lymphocytes are immune to ... virus infection but appear to maintain normal biological activities," they wrote.
The genetically modified lymphocyte immune cells live for months or years, so Chen's group hope the approach might offer a long-lasting HIV therapy.
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