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Issue #203: November 13, 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 Albany Times Union, Arizona Republic, Associated Press, Boston Globe, Business Wire, Chicago Tribune, DVHC Update, Kaiser Daily HIV/AIDS Report, Las Vegas Sun, New England Journal of Medicine, Philadelphia Gay News, Project Inform, Reuters Health Information Service, Washington Blade, Washington Post.
AZT after delivery can prevent infant HIV
Medicare may restrict viral load coverage
FDA panel backs approval of abacavir
Compromise okayed on Allegheny charitable assets
DEA suggests easier access to Marinol
FIGHT, Colours seek staff members
AZT after delivery can prevent infant HIV
A course of AZT can help prevent HIV transmission from mother to child even if the drug is first administered during labor and delivery, or first given to the infant 48 hours after birth, according to a report in the November 12th issue of The New England Journal of Medicine [1998;339:1409-1414,1487-1468].
The findings suggest that weeks of prenatal AZT (zidovudine) treatment -- which is known to substantially reduce the risk of transmission -- is the best but not the only way to reduce the risk of infected mothers transmitting the virus to their infants.
The findings are especially good news for the treatment of HIV-infected women in developing countries, which may not be able to afford weeks of expensive drug treatment for pregnant women.
"The drug-related cost of such prophylactic treatment of infants would be a fraction (less than 1/10) of that for even a short course of maternal treatment," according to an editorial by Dr. Kenneth McIntosh, of Children's Hospital, Boston, Massachusetts.
In the study of 939 infants exposed to HIV between 1995 and 1997, the HIV transmission rate was 6.1% when the mother was treated prenatally, 10% where the mother was treated during labor and delivery, and 9.3% for infants treated in the first 48 hours of life.
The transmission rate was 18.4% for those infants treated on the third day of life or later, and 26.6% for those not treated with AZT at all.
There are a number of reasons the women may not have received AZT during pregnancy, according to the report.
"Some women may not receive prenatal care, whereas others who do receive prenatal care may not be counseled or offered HIV testing," according to the report. The new study suggests that even if a woman had no prenatal care, rapid HIV testing of a newborn may still prevent transmission of the virus to an infant, reported lead author Dr. Nancy Wade of the AIDS Institute in Albany, New York, and colleagues.
Study co-author Dr. Guthrie S. Birkhead said that there is a potential role for rapid HIV testing in the delivery setting. "This has already been discussed somewhat in the medical literature... and our study shows that, indeed, there may be some benefit of doing rapid testing in the delivery setting." He pointed out that because many women are not tested for HIV during prenatal care, "it makes sense to try to identify these women at the time of delivery."
But to reduce perinatal HIV transmission "to the greatest extent possible, a combination of efforts is needed to ensure that all pregnant women receive HIV counseling and are tested for HIV and, if positive, receive prophylaxis with zidovudine, alone or in combination with other antiretroviral agents," the authors conclude.
Thomas "Ted" Kirk, one of the city's leading experts on AIDS and mental illness and a former board member of We The People, died of complications from the disease on October 26th. He was 31 years old.
A memorial celebration will be held for Ted at Keystone Hospice, 8765 Stenton Avenue in Wyndmoor, on Sunday, November 22nd at 1:00 p.m.
Born in Atlanta, Ted was informed of his HIV infection at the age of 18. But "he never stopped fighting," according to Pam Ladds, director of WISDOM. "He was a gentle person, but very tough on the inside. Ted empowered himself and others through his activism. He fought as long as he could."
Ted obtained his Ph.D. in clinical psychology in 1992 from the University of Edinburgh in Scotland. On coming to Philadelphia, he became involved with Philadelphia AIDS Coordinated Therapy Services (PACTS) and Philadelphia HIV Mental Health Services, which at the time were the only mental health programs in the region specifically for people living with AIDS. As a clinician at those agencies, Ted provided therapeutic counseling and other services to several hundred people with AIDS over the next three years.
After leaving the programs, Ted engaged in a long battle to appeal the denial of long-term disability benefits which he had earned as an employee. A compromise was eventually arranged with the agency after a demonstration by members of We The People and threatened legal action. Members of We The People and Project TEACH again came to Ted's defense only a month ago, when his Medicaid HMO refused initially to admit him to Keystone Hospice.
"Ted was a true leader in the struggle to help people living with AIDS and mental illness," noted Rob Capone, interim director of We The People. "He didn't stop with his own empowerment. He constantly shared his knowledge and experience with others helping fulfill our mission of taking care of each other. Ted will be sorely missed."
Ted was licensed as a "thanatologist," that is, an expert in grief and loss, and conducted many workshops around the country on issues related to death and dying. His presentations took on special urgency in recent years as his health began to deteriorate from the effects of his HIV infection.
Ted was also a leading advocate for people with AIDS, serving as co-chair of the Philadelphia HIV Commission, a quasi-governmental AIDS planning group, in addition to his membership on the We The People board. He also participated on numerous committees and advisory groups, including one which advocates to the state for improvements in medical coverage for poor people with AIDS.
Ted also was active in the SafeGuards Project, an AIDS education program of the AIDS Information Network, and with the Community Living Room, a self-help group of people with HIV and mental illness in center city.
In a 1995 interview with the Philadelphia Gay News on his election as the first consumer co-chair of the HIV Commission, Ted said he wanted to make sure that the AIDS funding process in Philadelphia was conducted fairly.
"One of my main goals is to understand how money is distributed in the AIDS system, and to convey that to other consumers," he said.
Ted was among the first people with AIDS to be admitted to Keystone Hospice, the new care facility for terminally-ill people with AIDS in Wyndmoor. Over the last year of progressively more serious illness, Ted was supported by a loving circle of friends, including Lee Walker, his primary caretaker; Anne Bizzup, Jean and Roger Greay, Rev. Kevin Porter, and Joanne Stato.
Ted is survived by his parents, Tom Kirk and Julia Richman of Tennessee, his brother David of Atlanta, and Mark Davis, his longtime partner, of Philadelphia.
Ted and Mark, who also served on We The People's board, renewed their commitment vows in a moving ceremony at the hospice only days before Ted's death.
"It was a very beautiful and touching ceremony," Yolanda Lollis, managing attorney at the AIDS Law Project, said of the event. "Ted refused to be denied life. He continued to live, right up to the end."
Medicare may restrict viral load coverage
The Health Care Finance Administration (HCFA), the federal agency responsible for administering the Medicare program, is considering a recommendation that would require people with AIDS covered by Medicare to use only one FDA-approved test to determine their viral load - even though the test is not considered the most sensitive or accurate available.
Brenda Lein of Project Inform says that this means is that "only the Roche PCR less sensitive test will be reimbursed" by Medicare, which is the primary insurance coverage for thousands of people with advanced AIDS symptoms.
Currently, according to Lein, states have been able to cover HIV RNA monitoring and testing reimbursements using any test that they find adequate. The new policy will only reimburse for the Roche test.
According to Lein, people who are following established standard of care guidelines and using more sensitive HIV RNA monitoring tests (e.g. limit of detection 50) will no longer be able to use these tests, or if they do they will have to pay out of pocket if Medicare is their source for reimbursement.
"Although this is a cost neutral issue, whether someone is using Chiron, Roche or OT more sensitive tests, they will no longer be covered," Lein said.
"For people who have been monitoring at labs that use technology other than the Roche PCR less sensitive test (Amplicor), baselines will have to be redrawn if they have to switch," she said.
Some labs have been trained and equipped to run the Chiron bDNA tests, and such labs will have to covert to the Roche technology and retrain staff if the HCFA recommendation is adopted. This may cause some delays in getting results and "will certainly have a cost impact" on labs not using the older version of the Roche technology, Lein continued.
Project Inform is recommendation that letters be written to HCFA asking the agency to refrain from issuing the new recommendation and that Medicare make available the technology for ultrasenstive HIV RNA testing, which is currently being recommended in revised federal guidelines for treatment of HIV infection. Letter should emphasize that this is a cost neutral issue, Lein recommended.
HCFA has posted the recommendations on its web page at http://www.hcfa.gov/quality/qlty-8a.htm. The address for correspondence is: Judy Ballard & Nancy Rubenstein, DHHS Departmental Appeals Board, Hubert H. Humphrey Building, Room 637D 200 Independence Avenue, S.W. Washington, D.C. 20201.
For more information, call Project Inform at 415-558-8669 x207.
The Food and Drug Administration's (FDA) Antiviral Drugs Advisory Committee has recommended accelerated approval of a new nucleoside analogue reverse transcriptase inhibitor (NRTI) for both pediatric and adult HIV-infected people.
Abacavir, to be sold as Ziagen by Glaxo Wellcome, is the first NRTI to be reviewed since 1995, and is the first to enroll children in pivotal studies at the outset. The FDA said the pediatric data were weak, but panelists disagreed.
Abacavir was tested in a two-pill regimen with Combivir, Glaxo's lamivudine (3TC)/zidovudine (AZT) tablet. Abacavir will likely be used with other NRTIs and protease inhibitors.
Committee members asked for more data on these combinations before granting full approval.
"We don't have all the data we'd like, but we have enough data to put this out there," said panelist Henry Masur of the National Institutes of Health. With accelerated approval, Glaxo is already required to produce more data to get full clearance.
Committee members also wanted Glaxo to guarantee it would work to inform patients and physicians about a hypersensitivity reaction. "I'm very concerned about the hypersensitivity reaction," said panelist Joseph Bertino, a pharmacologist at the Mary Imogene Bassett Hospital in Cooperstown, NY. "If this drug were in a different class it would probably not be approved."
It is not known which patients are at risk for the reaction, which includes fever, rash, nausea, and fatigue. It occurred in about three percent of patients in controlled studies. The syndrome tended to occur in the first 5-6 weeks, and dissipated with time, but therapy often was discontinued. When restarted, there was a danger of a fatal reaction. The FDA said eight deaths in all studies and the expanded access program--which has 11,000 patients so far--were due to hypersensitivity, but Glaxo said only one death was related.
Glaxo said patients should talk to their physicians if they had any symptoms. "The emphasis we want to make is patients should contact their physician, if not be seen by the physician," said Seth Hetherington, Glaxo senior research physician. Patients should be indefinitely removed from abacavir if they have the syndrome, Dr. Hetherington said.
In trials, abacavir reduced viral load at 16 weeks, but not significantly, said the FDA. The agency also pointed out that the drug only increased CD4+ cell count in the pediatric study.
An abacavir/3TC/zidovudine regimen was tested against placebo/3TC/zidovudine in treatment-naive adults, previously treated children, and for equivalence against indinavir/3TC/zidovudine in treatment-naive adults.
In the first study, 86% of abacavir patients had less than 400 copies per milliliter of HIV RNA, compared to 43% of controls. There was no difference in median rise in CD4+ cells between control and abacavir arms, with both showing positive effects.
Pediatric patients had a slightly more significant rise in CD4+ counts. HIV RNA also dropped significantly. But Glaxo said the effects weren't as pronounced as in adults, because of previous treatment.
In the 562-patient equivalence study, results were comparable between treatment A and treatment B, said the FDA, with about 60% of patients in both groups having less than 400 copies of HIV RNA per mL at 16 weeks. But there was a high drop-out rate of 24%, and the study results will not be accurately known until the 48-week point, said the agency.
Abacavir does offer convenient dosing, with one 300 mg tablet taken twice daily. That will reduce the number of pills taken, which some patients said would be a boon.
Jerald Breitman, a 51-year-old AIDS patient from Durham, NC, said his daily pill intake dropped from 28 to 11 capsules a day once he started abacavir. "The Ziagen/Combivir regimen has indeed given me back my life," said Breitman.
Some panelists and advocates said approval was premature. "It seems like we're pushing back the approval process further and further without a compelling reason to do so," said panelist John Hamilton of Duke University Medical Center.
Dr. Hamilton said he was worried about the hypersensitivity and the potential for creating new resistance.
While U.S. Bankruptcy Judge M. Bruce McCullough denied the Pennsylvania Attorney General Michael Fisher's motion for an Orphans Court review of a transfer of Allegheny Health, Education and Research Foundation (AHERF) charitable assets directly to Tenet Healthcare Corp., the court agreed to allow the attorney general's office to present a compromise to Orphans Court.
Tenet took over Allegheny's eight-hospital system this week. Tenet is the first national for-profit hospital chain to enter the Philadelphia health care market, raising concerns that low-income people will not be able to get quality care at some of the region's largest and most sophisticated hospitals.
As a result of McCullough's action, the Attorney General's Office, in a plan arranged with Tenet, has asked Philadelphia Orphans Court to approve the transfer of millions of dollars in charitable assets of the Allegheny health system to two new nonprofit organizations. The arrangement of who controls charitable assets needed to be resolved before Tenet could conclude its $345 million purchase of the hospitals.
One new nonprofit organization, Philadelphia Health & Education Corp., will take over the charitable restricted funds and endowments held by MCP-Hahnemann Medical School and Allegheny's three other professional schools. The new organization, which will own and operate the schools, would be managed by Drexel University.
A second nonprofit organization, Philadelphia Health & Research Corp., will administer the restricted funds and endowments of the eight hospitals. Between $50 million and $168 million in restricted funds and endowments are controlled by the university, and between $22 million and $25 million are held by the eight hospitals, said representatives of Allegheny and Tenet.
Also as part of Allegheny's reorganization, Judge McCullough issued an order allowing Allegheny to cancel the contracts of more than 40 doctors and faculty members, effective ten days after the order. About 60 more faculty members and researchers are expected to lose their jobs, university officials have said.
To date, the Allegheny bankruptcy crisis has not threatened the resources or services of the Partnership Health Care Clinic, which serves low-income people with AIDS at the Hahnemann site.
DEA suggests easier access to Marinol
The U.S. Drug Enforcement Agency (DEA) has issued a proposal that would reclassify Unimed Pharmaceuticals' dronabinol (Marinol) as a Schedule III drug instead of a Schedule II drug.
The action would result in increased patient access to Marinol, a synthetic THC (marijuana) compound that is approved by the Food and Drug Administration (FDA) for appetite stimulation in HIV-infected patients and patients on chemotherapy. The drug is currently being tested for its behavioral effects in patients with Alzheimer's disease and other forms of dementia.
Unimed noted that dronabinol's gradual onset of action means that "it has a very low potential for abuse." The company said that the DEA had consulted with the FDA before proposing the reclassification of the drug.
The DEA's announcement came as voters in Nevada, Arizona and Washington approved the use of medical marijuana on November 3rd, while Congress blocked the announcement of results from Washington, DC.
Washington state passed Ballot Initiative 692 59% to 41%, which will allow patients suffering from severe pain to grow and possess a 60-day supply of marijuana. Rob Killian, the Seattle physician who sponsored the measure, said, "We worked hard to bring back a very tightly worded, specific medical marijuana initiative. It's a model for the rest of the country."
Supporters of Nevada's Question 9 bested the opposition 59% to 41%, but the measure must be reapproved in the 2000 election prior to becoming law. The Nevada attorney general's office has said the measure will not be implemented until the federal prohibition against medical use of marijuana is overturned, however.
Arizona supporters of medical marijuana voted to reinstate a 1996 state law allowing doctors to prescribe marijuana for terminally ill patients by defeating Propositions 300 and 301 by 57% to 43%.
Sam Vagenas, spokesperson for the People Have Spoken, which launched a $1.6 million campaign opposing the propositions, said, "This has been both a referendum on the war on drugs and a referendum on our failing politicians."
A medical marijuana ballot measure also passed in Oregon and Colorado, although in Colorado, Secretary of State Vikki Buckley had previously ruled that supporters fell short of the number of signatures necessary for the measure to be valid.
Meanwhile, in the District of Columbia, the Board of Elections decided that results from the vote on Initiative 59 cannot be announced under a congressional mandate barring the use of government funds to certify the results. However, an exit poll conducted by Americans for Medical Rights, which supports the measure, surveyed 763 voters and found that 69% support the measure, with a 3.6% margin of error.
Kenneth McGhie, general counsel for the Board of Elections, said that with ballots already printed and computers prepared to count them, the cost of announcing the results would be "very, very minimal."
After the election, U.S. District Court Judge Richard Roberts denied a motion filed by the American Civil Liberties Union (ACLU) to allow D.C. election officials to tabulate and release the results of the vote on the medical marijuana initiative.
The ACLU lawyers argued that a recently-passed congressional amendment "violates the First Amendment rights of D.C. residents to vote and be heard on an important issue." D.C. Corporation Counsel John Ferren said, "Every day we are not having these ballots counted, our rights are violated."
Last month, Rep. Bob Barr (R-GA) sponsored the amendment to the D.C. Appropriations Bill, prohibiting the District from spending money on any initiative that would "legalize or otherwise reduce" penalties for users of marijuana.
The lawyers were thwarted in their effort to secure a temporary restraining order to learn the results, after the federal judge "said he wants to take a comprehensive look at the legal issues stemming from the congressional amendment. Roberts set a hearing date for Dec. 18, frustrating D.C. officials with a five-week hold on the information.
The Washington Blade, a gay newspaper, reported that the California-based Americans for Medical Rights financed exit polling on election day that showed the initiative may have passed. Of the 670 polled who voted on the measure, 69% voted in support and 31% voted against. ACT UP/D.C.'s Wayne Turner, the primary sponsor of the initiative, said, "This means that our celebration of our victory is just delayed a little longer."
The passage of the ballot initiatives approving the use of smoked marijuana for medical purposes has reinvigorated the debate of the use of the drug.
In 1997, a National Institutes of Health (NIH) panel said that there is still no substantial research into the drug's medical efficacy. The panel found, however, "that existing research showed some patients can be helped by the drug, principally to relieve nausea after cancer chemotherapy or to increase AIDS patients' appetites." NIH Director Dr. Harold Varmus said at the time that applications for marijuana research were welcome, but the agency has approved only one project, a study of smoked marijuana in AIDS patients."
Scientists assert that the difficulty of designing a viable study often hinders their efforts. Drug companies hesitate to invest in such research, and scientists have problems creating a placebo that accurately replicates the experience of smoking the drug.
Dr. Reese Jones, a marijuana researcher at the University of California-San Francisco, said that "There isn't a government conspiracy to discourage it. The issue is, what else are we not going to do in order to pay for it?"
A Chicago Tribune editorial after the November 3rd election contended that "opponents of medical marijuana have yet to make a convincing case why cannabis should not be available to people who need it to relieve serious ailments." The paper noted that while "the medical potential of pot is undeniable by now ... critics say there is a dearth of serious studies documenting marijuana's value. But that's because the National Institute on Drug Abuse, the only legal supplier of cannabis, has been reluctant to facilitate such research."
While the editorial urges policy makers to commit research funds to confirm or deny the drug's efficacy, it recognizes that the allocation of funds to "such studies would require elected officials and bureaucrats to concede that cannabis may not be an unmitigated evil." The editorial concludes: "So far, such open-mindedness is far more common among ordinary people than among those who make policy."
Similarly, the Albany Times Union urged the Clinton Administration to "pay heed" to the recent public approval of medical marijuana, asserting that "there's no basis for the White House contention that the push for the use of marijuana for medicinal purposes is really a front of a movement to legalize other drugs." The paper notes that with "scientific evidence on the popular side," efforts to make medical marijuana use illegal are "an unfair attack on ... efforts to ease suffering, and nothing more."
After months of missed bill payments and delayed payrolls arising out of delays in city reimbursements for its services, We The People has finally received most of its outstanding payments and has been able to pay its bills and its staff on time.
We The People faced the most serious financial crisis since its founding in 1987 over this summer, when officials at the city's AIDS Activities Coordinating Office (AACO) met with bureaucratic delays and lost paperwork in processing several of the agency's basic contracts.
Rob Capone, interim executive director of We The People, said that the arrival of over $100,000 in late payments from the city and approval of a larger credit line by a local bank had allowed We The People to erase the mounting debt of the summer and restore a firmer financial footing as of early November.
Capone also thanked Michael Hinson, executive director of The Colours Organization, for arranging a $10,000 loan to We The People from his agency at the height of the fiscal crisis, so that the staff and volunteers could be paid. "I really appreciate what Michael did for We The People" Capone said. "We have a long history of working together on issues of helping people living with and at risk for HIV infection and his sensitivity and response to our crisis is commendable."
Capone said that payments for emergency housing and other assistance through We The People's LifeSavers Emergency Fund were not affected by the financial crisis, because We The People keeps those funds in a separate account and has a policy which prevents those funds from being used for the agency's regular operations.
"We're very grateful to Joe Cronauer, Dwight Martin and other members of the AACO staff for giving priority to helping us get through the red tape and overcome bureaucratic ineptitude in the city's payment system," Capone said. "But we remain concerned that small organizations like ours, which are almost totally dependent on public funds, are forced to wait and wait and wait for the funding we've earned while city staff continues to get paid without interruption."
Capone said that while We The People is also pleased to have expanded its credit arrangement to help prevent future crises, the agency will only worsen its financial position in the long term because of high interest rates. "The city forces us to borrow money because it won't pay its own bills on time," Capone said. "Then it tells us that we have to cover the interest payments ourselves - we can't pass that cost along to them. That's really unfair, and it means that the longer they take to pay their bills, the more expensive it's going to get for us."
Capone also noted that the continuation of the agency's credit arrangement could be threatened if city delays result in delays in payments to vendors, negatively affecting the agency's credit worthiness.
Noting that almost all AIDS agencies dependent on public funds have faced the same crises - some even being forced to close their doors or severely restrict operations over the years - Capone said that AACO and the Philadelphia HIV Commission need to give more urgency to addressing the problem.
"Several years ago, AIDS service providers asked the city to work with local banks to set up a payment system that assure faster reimbursements and left the city with the burden of paying the interest costs," Capone said. "That effort seems to have fallen by the wayside. I think it's time we all started looking into that again."
Philadelphia FIGHT and The Colours Organization are seeking new staff members to fill pivotal positions at the agencies.
FIGHT is engaging in a national search for a new Director of Education to oversee its internationally recognized educational programs, which bring state-of-the-art HIV treatment information to a diverse range of people affected by HIV/AIDS in the Philadelphia region.
The Director coordinates all aspects of educational programming, including Project TEACH, an innovative secondary prevention and activist training program for people with HIV. The director also plans and implements two monthly community updates as well as special educational events such as AIDS Education Month and quarterly peer education conferences.
Extensive experience in HIV-related treatment activism or health education are required. The Director must develop innovative curriculum and engage in community-based education and instruction.
For more information, call Julie Davids at 215-985-4448 or email jdavids@critpath.org
Colours, the region's leading organization of sexual minority people of color, is seeking an operations director, a director of its youth programs, and an administrative assistant. For more information, call Michael Hinson at 215-496-0330 or email mshinson@critpath.org.
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