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Issue #199: October 16, 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 articles in this issue include AIDS, Associated Press, Biology of Reproduction, Seattle Times.
Abington School District sues student for medical records
Drug-resistant HIV found in semen
WTP joins Lax Center to expand medical services
Red tape threatens local AIDS agencies
Budget deal increases SSI - by $6
Positive news on spermicide front
Needle exchanges grow despite US ban
Glaxo supports local prison programs
Washington board endorses names reporting
Panel: All pregnant women should be tested
Roche study asks if men, women respond differently to Fortovase
Abington School District sues student for medical records
The Abington School District has sued the parents of an HIV+ boy to obtain a copy of his medical records for distribution to school staff.
The school district says it needs the medical information in order to find out if the child has any "secondary infections," and make sure that the student's HIV infection won't be a threat to other students. The district went to court when the student's parents refused to sign a form authorizing the school district to access their son's medical records.
"All we want for them is to sign this authorization for us to get the information that the student does not have any secondary infection, said Michael Kristofco, a school district attorney. "We want to make sure that there's nothing else we're not aware of."
The district's legal action seeks to enforce a policy on HIV+ students that was adopted in the late1980s and was updated only last month. Under the policy, an HIV+ student's medical records are shared with the school principal, the assistance principal, the school nurse, the nurse's clerk, and a school district medical advisor.
The policy also calls for the school to form a committee to figure out "appropriate educational and social alternatives as they relate to school and school-related activities" if they believe the child represents a risk to other students.
A spokeswoman for the U.S. Centers for Disease Control (CDC) told the Montgomery County Record that she had never heard of a school district going to court to get this kind of information. "I have heard of parents suing school districts for denying their children access to education," she said. "I haven't heard of it the other way."
Another CDC spokesperson told the Record that the suit didn't make a lot of sense to her. She said that "There aren't any illnesses an HIV+ child could have that couldn't occur with a child without the illness," and noted that the HIV+ child is actually at more risk of infection from other schoolchildren then a risk to them.
Abington school district superintendent James McCaffery said that this is the first time the policy on HIV+ children has been used in the district.
Nan Feyler, director of the AIDS Law Project of Pennsylvania, which is representing the family, said that she believes the Abington policy violates both state and federal confidentiality protections and the Americans with Disabilities Act.
"There is no justifiable reason for a school to have access to a student's private medical records," she said. "It's not like active tuberculosis."
"We're outraged by the policy and the demands of the school," Feyler continued. "They don't represent current medical knowledge of HIV."
"There are thousands of kids with HIV in schools and they don't post a threat to anyone else," added Scott Burris, a specialist in HIV legal issues. "It should be sufficient to get the same medical information as everyone else - that he doesn't have any communicable diseases and has had his shots."
Burris called the district's action "preposterous, medically preposterous."
"This is just hysteria and foolishness and a waste of taxpayers money," Burris continued. "And that's whether they win or lose."
The child continues to attend school while the family and the district discuss a resolution to the suit.
Once in the body, HIV can evolve in different ways in the blood and semen, so that genetically different strains of the virus can be found in a single individual, a new study suggests.
Part of the reason may be that the antiretroviral drugs used to fight HIV effectively combat virus in the blood, but are less effective at suppressing virus found in the genital tract, the study indicates.
Incomplete suppression of the virus in the genital tract may promote formation of drug-resistant strains of virus, according to the report in the October issue of the journal AIDS. Sexual transmission of such resistant viruses may make HIV infection more difficult to treat in a newly infected individual.
"Therapeutic strategies that fully suppress HIV-1 in the genital tract should be a public health priority," reported lead author Dr. Joseph Eron, a professor of medicine at the University of North Carolina at Chapel Hill, and colleagues there and in Switzerland.
The researchers studied 11 men undergoing treatment for HIV. They found that more than half had HIV levels in the semen greater than levels found in blood.
"The current study further adds to previous studies demonstrating that HIV-1 in the male genital tract is in a biologically separate compartment," according to the report. The researchers also found substantial genetic variation between virus in the blood and semen, according to the report. Two of the patients treated with protease inhibitors had genetic indicators that virus in the blood was becoming resistant to the drugs, while virus in the semen had no such indicators -- suggesting that the drugs were not penetrating the genital tract.
The authors concluded that the reduction of HIV viral loads generally through the use of combination therapies, while obviously beneficial, may be an incomplete attack on the virtus. "Complete suppression of HIV in the semen may, however, be necessary to prevent the evolution of resistant variants in this compartment and therefore should be a goal of antiretroviral therapy."
"This paper is important because it clearly documents that sexual fluids or genital secretions do contain resistant virus, so the fear that there is some spread of resistant HIV is founded on logical scientific evidence," Eron said. The mutated HIV strains include those less susceptible to suppression by a spectrum of front-line AIDS medications including zidovudine (ZDV or AZT), didanosine (ddI) and lamivudine (3TC) .
Eron, a infectious disease specialist, points to a case report last summer in The New England Journal of Medicine of infection with a strain of HIV that was resistant to multiple antiviral medications.
"Our study shows how this can happen," he said. "It is also the first to demonstrate that if men -- and presumably women -- do not have adequate suppression of their virus, as measured by levels of the virus in their blood, they are very likely to shed drug-resistant strains of HIV in their genital secretions. And that is virus that's available for transmission."
Previous research at Carolina and other centers has shown that effective treatment with the commonly used cocktail of antiviral medications typically is associated with suppression of the virus both in blood and semen to below detectable levels.
"But the men studied in this new report continued to have detectable virus within their blood and semen, even in the face of what we intended to be effective therapy," Eron explained. "These men shed resistant virus and the virus became more resistant over time."
The new study focused on 11 HIV-infected men in North Carolina and Switzerland, most with a history of having sex with men, but not exclusively. Five of the 11 had never taken drugs for HIV. Six had received previous treatment with reverse transcriptase (RT) drugs, which are designed to block HIV from delivering its DNA into the cell. All subjects were identified with detectable levels of the HIV both in their blood and semen when the study began.
At the beginning of the study and periodically up to 58 weeks, the researchers measured the amount of HIV in the men's blood and semen while they received a new program of antiviral therapy. The therapy included a variety of antiviral AIDS drugs.
"What we showed was that men who had previous treatment already had evolved virus in their blood and genital tract that contained mutations known to decrease the susceptibility of that particular virus strain to the available drugs," Eron explained.
Moreover, when men with drug-resistant HIV in blood and semen were followed over time they continued to acquire higher levels of resistance while receiving antiviral therapy, Eron said.
Three of the six patients with previous RT experience showed evidence of RT-resistant HIV in their semen and continued to do so as treatment went on. And eight of 10 whose HIV was genetically analyzed as the study continued showed new resistance mutations in their blood or semen, or both.
"We need to emphasize not only for personal health, but for public health, that the goal of treatment should be to get the virus to unmeasurable levels, both in the blood and other biological compartments, specifically the genital tract," Eron said. "We also need to understand more about our drugs. In other words, do our drugs get into the genital tract both in men and women? Is there some block to that and are they getting in at levels high enough to suppress the virus?
"The better we understand these issues, the better we'll be at trying to prevent the spread HIV."
We The People has forged a collaboration with the Jonathan Lax Immune Disorders Treatment Center to provide comprehensive, state-of-the-art HIV care at We The People's Life Center. Helena Kwa Kwa, MD, an HIV experienced physician, will now hold one clinic session per week at the Life Center on Tuesday evenings from 5:00 to 8:00 PM, and patients will also be seen at the Lax Center on Thursday evenings, located a few blocks away at 1233 Locust Street.
This collaboration represents a significant expansion of medical services offered through We The People. Rob Capone, We The People's Interim Director, said, "For years now, we have only been able to offer basic diagnostic services and laboratory tests at the Life Center. But the communities served by We The People need better access to the full range of medical services. Working with the Lax Center will allow us to insure that anyone who comes into We The People will have access to state-of-the-art care."
The collaboration was launched because We The People has become concerned that recent changes in the health care system may prevent people from low income communities and communities of color from gaining access to high quality HIV care. Capone said, "Every day, we hear complaints about bureaucratic hurdles that people are forced to jump through in order to get access to care, and we also hear horror stories about the substandard care that people receive from providers who are not experienced in AIDS care. The advent of HealthChoices and the bankruptcy of the Allegheny hospital system have made many people fear that they are not going to be able to get the care they need to survive. Our collaboration with the Lax Center will insure that people who can't get high quality care elsewhere will now be able to get it here."
This collaboration is the latest in a series of successful collaboration with Philadelphia FIGHT, the Lax Center's sponsor. Jane Shull, Philadelphia FIGHT executive director said, "We are very pleased to be working with We The People, with whom we have collaborated many times in the past. We The People has served an historic role in linking HIV positive people from under-served communities to life-saving HIV services. This is a wonderful opportunity to combine forces to reach our shared goal of providing access to high quality AIDS care for all people, regardless of their ability to pay."
We The People is the region's largest coalition of people living with HIV and AIDS. Through its Life Center, it provides a range of social services including housing, a daily meals program, food and clothing banks, emergency financial assistance, support groups and several HIV prevention programs. It also runs the Living Positive Treatment Center, a drug and alcohol program for people with HIV and AIDS. For more information about the Lax Center initiative or other We The People services, please call (215) 545-6868.
Increasing delays in payments on invoices by the city health department are threatening the ability of some AIDS organizations to stay open to serve PWAs, according to several agency directors.
We The People interim director Rob Capone said that the organization was unable to give paychecks to its regular employees this week because the city owes over $95,000 in bills for services stretching back to last July. He said that We The People policy is that priority for any cash in the bank goes to emergency financial assistance for PWAs, with the second priority being stipends and reimbursements for PWAs who volunteer at WTP's Life Center. After making those payments, there was not enough money to meet the weekly payroll for regular staff, Capone said.
The delay also affected paychecks for the staff of WISDOM, the local PWA women's group, which receives its public funding through WTP.
Another agency, which asked that it not be identified in fastfax, says it is owed over $250,000 by the health department and may miss a payroll in the coming weeks.
While delays in city payments to AIDS service organization have been common for many years, the situation has gotten more serious this year because the city has encouraged more agencies to directly contract with the AIDS Activities Coordinating Office (AACO), rather than contracting through third-party conduits as had been the system since 1988.
Under the conduit system, the city contracted with two organizations - Philadelphia Health Management Corporation and the Greater Philadelphia Urban Affairs Coalition (GPUAC) - and those two agencies subcontracted with AIDS service organizations. In practice, the conduit system meant that if an agency experienced a cash flow problem, it could get paid by the conduit agency even if the city had not yet paid the conduit itself.
Both city officials and AIDS advocates became increasingly concerned in recent years, however, at the administrative costs associated with the third-party arrangements. Political disputes between minority AIDS groups and GPUAC also led many groups to disengage from the conduit contracts and directly contract with the city on their own. However, many of those groups are now finding that long delays in "conforming" city contracts and making payments are threatening their viability.
AACO officials have attempted to assure that all approved invoices to the city are paid within 45 days of their submission, but in practice this goal is often not achieved. AACO itself is only the first step in a 13-phase approval process for city payments, and it is not unusual for contracts and invoices to inadvertently get misplaced or for the numerous other city agencies and departments involving in the check-writing process to move slowly in making payments. Capone said that one reason for the delay in reimbursing WTP for its services, according to AACO officials he spoke to, is that the WTP contract was delayed for weeks while a Law Department employee was on vacation.
Larger AIDS agencies have negotiated credit arrangements with local banks to help them cover their expenses while awaiting payment from the city, but most directors contacted by fastfax said that those arrangements were themselves a cash drain on the agency.
"The problem with the whole credit line concept is that it basically forces a non-profit agency to borrow money on behalf of the city and then pay interest to the bank," said Capone. "Since the city won't reimburse us for the interest, we are in effect lending the city the money and than losing the cost of the interest forever."
"Our budget is about $1.7 million a year," Capone continued. "The city's is over $2 billion. Something doesn't make sense here."
Capone said that the city needs to develop a mechanism through which payments on contracts with small non-profits are expedited. "We The People isn't some enormous construction company or law firm that can afford to wait to get its bills paid," he said. "We're people with AIDS busting our behinds every day to get the job done on very little money, almost all of which comes through the city. There has to be somebody in City Hall who can recognize that small organizations like ours, almost totally dependent on the city paying its bills, deserve to be treated a little better. Our staff didn't get paid this week - but the people holding up our money all did. That's not fair."
AACO officials said they were investigating the delay in WTP payments and will try to get a payment to the agency in the next two weeks.
The budget agreement worked out this week by President Clinton and the Republican Congress contains a cost-of-living increase for those receiving Social Security Supplemental Income (SSI) payments - but it only comes to $6.00.
The increase will be included in checks beginning in January.
Recipients of Social Security Disability (SSD) checks will also receive the increase, at the rate of 1.3 percent. For most SSD recipients, the increase will amount to about $10 per month, depending on the current amount they receive.
SSI is the program which provides disability benefits to low-income individuals who have not worked enough to contribute to the Social Security system; SSD covers individuals who have contributed to Social Security.
The increase in January is the smallest since 1987. Some critics have said that even this increase is too much, because they question how the government measures cost-of-living increases and say that inflation has been so low this year that no increase is necessary.
Scientists at the Hughes Institute have developed spermicides that may act as dual-function vaginal contraceptives that also prevent the sexual transmission of HIV.
The microbicide compounds may be especially useful for women who are at high risk for contracting HIV by heterosexual vaginal transmission -- the method of contraction for more than 75% of newly reported HIV infections worldwide.
In the absence of an effective prophylactic anti-HIV vaccine or antiretroviral therapy, the Hughes Institute reports that female-controlled vaginal contraceptives which curb HIV transmission and protect against sexually transmitted diseases are being sought. Published in Biology of Reproduction, the scientists' results reveal that in comparison to the spermicide nonoxynol-9, the newly synthesized microbicide compounds are 400 times more potent anti-HIV agents and at least 10 times more effective spermicidal agents. While nonoxynol-9 has been touted as an effective spermicidal and antiviral agent for more than 30 years, its effectiveness at reducing transmission of HIV and other sexually transmitted diseases is limited. The detergent properties of nonoxynol-9 cause it to disrupt cell membranes and trigger inflammatory responses, enhancing the likelihood of HIV infection. The researchers note that the newly developed microbicides lack the disruptive properties of nonoxynol-9, while maintaining potent anti-HIV and spermicidal properties.
A Centers for Disease Control and Prevention study has found that the number of syringe-exchange programs (SEPs) has expanded significantly over the past several years, despite the refusal of federal officials to authorize the use of federal money to support them.
The results of the comparative study found that of 100 SEPs surveyed, there was a 3.5 million increase in the number of syringes dispensed between 1996 and 1997, with 17.5 million syringes exchanged in 1997. The survey also showed that almost all of the programs include safe sex education, safer injection instruction, and substance abuse treatment referral.
The Baltimore City Needle Exchange Program offers drug treatment on demand. Wendy Royalty, director of legislative affairs for the program, explained: "If they [addicts] have to wait, you lose them. If they are ready [for treatment], we want to give them the opportunity."
Nearly two-thirds of the programs offer HIV testing and counseling on-site, while about 20 percent provide tuberculosis skin screening, sexually transmitted disease screening, and/or primary health care.
Fifty-two of the SEPs studied were legal, while 16 were illegal but tolerated and 32 were illegal and underground. Just over half of the programs were in California, New York, Connecticut, and Washington state.
An attempt by officials in Washington, D.C. to use public funds for a local needle exchange program was defeated by Republicans in the U.S. Congress as part of the federal budget deal announced this week.
Glaxo supports local prison programs
In an effort to improve care for prison inmates with HIV/AIDS, both during and after their incarceration, Glaxo Wellcome has announced it has awarded approximately $400,000 in grants to 19 nonprofit organizations nationwide, including several in the Philadelphia area.
The grants will support outreach and case management services, educational materials and presentations, hotlines, peer-education and transition programs and treatment advocacy services.
Local organizations receiving Glaxo's support for their prison-related initiatives include ActionAIDS, which received $10,000, the AIDS Coalition of Southern New Jersey ($30,000), and the Berks AIDS Network in Reading ($10,000).
ActionAIDS has been providing case management in the the county prisons for the past eight years, according to Kevin Conare, ActionAIDS executive director. The organization's prison case manager assures that prisoners get appropriate medical care, are linked to services on the outside when they are released, and, when necessary, advocate for compassionate release.
Conare said that this year ActionAIDS is working closely with the AIDS Law Project and the city's AIDS Activities Coordinating Office (AACO) to make sure that prisoners who are receiving appropriate medical treatments and have continuous access to them and immediate services upon release. AACO, which has supported HIV prevention and education programs in the city prisons since 1988, is planning to appoint a new social worker to its staff to help HIV+ city prisoners in the near future.
Conare said that Glaxo grant to ActionAIDS was particularly timely, because the organization lost half of its prison-oriented funding from the Philadelphia AIDS Consortium earlier this year. "This funding makes sure that we move forward instead of backwards," Conare said.
Despite earlier indications that the state of Washington would join Illinois and Massachusetts in using a code-based system for required reporting of people with HIV, the Washington State Board of Health has voted 7-0 to draft a rule that would add HIV to the list of reportable communicable diseases and require doctors to report the names of everyone in the state who tests positive for HIV."
The decision differs from the recommendation put forth by Gov. Gary Locke's Advisory Council on HIV/AIDS for a program that utilizes "unique identifier" codes. Under the new rule, patients would still anonymously be tested for HIV, but their names would be forwarded to a government database once they sought treatment.
Steven Johnson, communications director for the Northwest AIDS Foundation, said, "Without a confidential unique identifier system, there's no way to convince folks to move forward and seek treatment." Referring to the amount of public resistance to the names-reporting system, Johnson said, "The board may have the authority to change the rules, but it takes two to dance in this game, [and] I think public health will be dancing alone."
A group known as "Resist the List "said it would do everything, including civil disobedience, to protest the policy.
Meanwhile, the Georgia Task Force on AIDS has recommended the use of numeric codes instead of names to report the cases of HIV to state authorities.
The task force delivered its non-binding recommendation to the state Department of Human Resources, which says it will continue to seek public comment on the issue until it renders its final decision in the summer of 1999 and begins implementing the program in 2000. Task force member Dr. Harold Katner, who treats HIV-positive patients in Macon, said, "If we don't get those numbers out, there's no way I'm going to get funding. I don't know how else we can set up programs to deal with areas with a high growth rate."
Panel: All pregnant women should be tested
Testing all pregnant women for HIV could reduce the number of babies born with HIV and should become part of routine prenatal care, an independent advisory panel has told Congress.
The Institute of Medicine report follows an review of the existing research and opinion on preventing mother to child transmission of HIV.
The recommendation is likely to be controversial. Many AIDS experts say testing all women who become pregnant each year could further reduce the number of babies born with HIV.
Even though HIV testing is becoming more common, many doctors, including the American Medical Association, believe routine testing is not needed since a vast majority of pregnant women are not infected.
Of the more than 4 million women who become pregnant each year, just 8,000 are estimated to be infected with HIV.
Some fear inaccurate test results that show a woman is HIV-infected could cause unnecessary stress.
"Without proper pre-test counseling ... there will be a lot of people unduly alarmed," said Dr. Michael Greene of Massachusetts General Hospital, a spokesman for the American College of Obstetrics and Gynecology.
Current federal HIV treatment guidelines advise doctors and other health care providers to give extensive pre-test counseling to all pregnant women and to help them understand the benefits of HIV testing.
However, many doctors who testified before the institute said counseling their patients on HIV is a burden and many don't do it.
Most experts believe that much can be done for a pregnant woman who tests positive for HIV. Taking the drug AZT can dramatically cut the chances she will pass on the virus to her child, according to several studies. The use of AZT has cut the number of HIV infected babies born by 43 percent between 1992 and 1996.
"The message to women is, this is a disease for which we can do a great deal right now," said the chair of the study, Dr. Marie McCormick of Harvard University. "If you find you're positive, there's a great deal we can do to keep you healthy and, more importantly, to prevent transmission to your child."
In 1996, 1,600 babies where born with HIV, and the government says at least 432 babies were diagnosed with full-blown AIDS last year.
The Centers for Disease Control and Prevention said it will consider the recommendation, but that pregnant women would need to know some basic information on HIV before being tested.
The Institute of Medicine recommended the HIV test be included with other routine tests commonly given to pregnant women, such as the test for syphilis.
It did caution, however, that routine testing will not eliminate HIV births since AZT isn't foolproof and 15 percent of HIV-infected women don't seek prenatal care, according to studies.
Roche study asks if men, women respond differently to Fortovase
Hoffman-La Roche, the makers of the protease inhibitor Fortovase (saquinavir), has announced it will conduct the first investigational study to examine the difference between men and women's response to anti-HIV therapy within the same study.
The study will evaluate and compare the response of women and men to Fortovase in combination with two nucleoside reverse transcriptase inhibitors (NRTIS) in HIV-positive patients.
"This study is a critical step forward in better understanding the treatment of HIV/AIDS in women," said Carmen Zorrilla, MD, professor of obstetrics and gynecology at the University of Puerto Rico School of Medicine and principal investigator of the trial. "Recent statistics show that women comprise 45 percent of new HIV infections, but they account for only 9 to 15 percent of research study participants."
The trial is designed to determine whether gender differences exist in response to anti-HIV treatment, including viral suppression and CD4 cell count. The study will also compare viral load levels in vaginal secretions to that in the blood, to determine whether decreased viral load in the blood is reflected in a similar decrease of viral load in the tissues, or conversely, whether the vaginal area remains an HIV reservoir, hiding the virus from treatment.
The trial will also attempt to answer the question of whether there are drug interactions between Fortovase and oral contraceptives that might affect the efficacy of either drug. In order for physicians to determine effective birth control methods for their HIV-positive patients, the relationship between Fortovase and oral contraceptives must be understood, a company announcement said.
"Historically, the treatment of HIV/AIDS has not focused on women. This is a fast-growing population for the epidemic, yet women are understudied," said Dr. Sandra Palleja, medical director at Roche Laboratories. "At Roche we have put women's research at the forefront of our clinical program to address women's treatment needs."
The open-label study is expected to enroll 60 women and 20 men in 20 centers nationwide. For more information on this trial, call 1-800-TRIALS-A.
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