|
 |
|
|
|
Issue #233: June 11, 1999
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 the fastfax index page. Information in fastfax is drawn mostly from secondary sources; people living with HIV/AIDS should share information of interest to them with their primary care provider before making treatment choices. For more information on HIV medications and treatments, contact Kiyoshi Kuromiya of the Critical Path AIDS Project, 215-545-2212 or by email to The presence of the name or image of any individual in fastfax should not be construed as an indication of their HIV status or sexual preference unless specifically stated. Questions or comments should be directed to Editor, fastfax, 425 S. Broad St., Phila., PA 19147-1126 or by email to
In This Issue:
Harrisburg gets bill requiring HIV code reports
Study says 2 PIs better than one
Advances made in detecting HIV dementia
GMHC workers mutiny over firing
Rite Aid sued for selling expired condoms
Africa bill reappears in Congress
State College group seeks director
Pennsylvania House Rep. Pat Vance of Camp Hill has proposed a bill that would require Pennsylvania to collect reports of HIV infection using "unique identifiers," or codes, rather than full names, according to Bruce Flannery, director of the Pennsylvania Coalition of AIDS Service Organizations (PCASO).
The bill is know as HB 1487, and has 38 sponsors, including some conservative legislators who apparently support it out of concerns for protecting the privacy of Pennsylvanians, according to Flannery.
In a report to PCASO members and supporters, Flannery said that Vance's bill comes after a long discussion with the chairperson and staff of the House Health and Human Services Committee.
Pennsylvania governor Tom Ridge is expected to announce the state's decision on how it will require reporting of HIV infections - by names or codes - by the end of the summer, with a formal implementation date of January 1, 2000.
Ridge is expected to hear a report from state health department officials who conducted eight public hearings around the state on the issue over the past few months. Flannery said that it is not expected that the group will propose a specific recommendation to the governor, but instead will just report on the testimony received at the hearings.
Most of those who testified at the meetings supported requiring HIV reports, but opposed the use of names and other identifying data in doing so.
Flannery said that it is possible that hearings on HB 1487 will be held this summer, during the time that Ridge will be considering his decision. Since those hearings would likely hear major testimony opposed to names reporting, "this might help move the tide in a new direction," Flannery said.
Another possibility, Flannery said, is that the Governor could announce a regulation requiring names reporting and the bill could pass the legislature anyway. If that occurs, the legislative action would supersede the Governor's action - although Ridge would have to sign the bill for it to become law.
Philadelphia's health department has formally opposed names reporting, as have several other health boards and committees in other counties. However, most states require names in HIV reports, and it is considered unlikely that Ridge will support the use of unique identifiers unless he believes that the decision would result in ongoing controversy that might hamper his political ambitions, according to several Harrisburg sources.
Presentations by state health department officials in the public hearings this past spring focused on the advantages of names reporting and emphasized the disadvantages of a unique identifier system, leading many to believe that the decision to require names has already been made and that the hearings and debate are only a process to allow advocates to believe that they have been fully consulted before the action is announced.
Back to Top
The rate of hospitalizations for HIV-related illness dropped approximately 30% between 1995 and 1997, according to new data released by the National Center for Health Statistics (NCHS).
Data from the National Hospital Discharge Survey, an ongoing study that includes medical records from nationally representative hospitals, indicate that there were 71,000 fewer HIV-related hospitalizations in the US in 1997 than in 1995. This reflects 878,000 fewer days of hospital care, representing a 40% drop during the 2-year period.
"The decline in hospital use is consistent with the declines that have already been reported for mortality and morbidity" resulting from HIV infection, one of the study investigators, Dr. Jean Kozak said. Like the declines in morbidity and mortality, she credits the falling hospital use rate to intensive antiretroviral drug treatment of HIV-infected patients.
The new report, entitled "Decreasing Hospital Use for HIV," is published on the NCHS Internet page as the first in a series of NCHS Health E-Stats, available at http://www.cdc.gov/nchswww.
Other important findings include a 60% drop in the number and rate of HIV-related hospitalizations in the West, the largest decline for any region in the US. According to Kozak, this finding is consistent with HIV mortality data for 1995 and 1996. "Certainly for that period, the largest decrease in HIV death rates was in the West," she said.
Specific age groups also experienced larger than average declines in HIV-related hospitalizations, according to a statement from the NCHS. These include 30- to 34-year-olds, in whom the number of hospital days for HIV-infected patients dropped by 50% between 1995 and 1997, and patients aged 25 to 29 and 40 to 44, in whom the decline was greater than 40%.
The new findings are "good news," Kozak said. Together with the reported declines in morbidity and mortality associated with HIV infection, the hospitalization data indicate "that progress is being made." (Reuters)
The combination of ritonavir (Norvir) plus indinavir (Crixivan), both given at 400 mg twice a day, makes for a much more convenient antiretroviral regimen, freeing patients from the normally rigid dosing requirements when taking indinavir alone. The reduction in indinavir dose virtually eliminates the risk of nephrolithiasis, yet the regimen maintains potent suppression of viral load.
Dr. Cassy Workman, associate director of the AIDS Research Initiative, Sydney, Australia, presented findings at an HIV Weekend Program here, sponsored by Abbott Laboratories, the manufacturer of Norvir. She described her own and others' work on the pharmacokinetic and clinical effects of combining the two protease inhibitors at specific doses of 400 mg, twice a day, for both ritonavir and indinavir.
At 400 mg, twice a day, but not lower doses, ritonavir optimally changes the metabolism of indinavir in the liver, so that clearance is much more gradual, Dr. Workman explained. Combining the two protease inhibitors also increases concentrations of both ritonavir and indinavir so that the net effect is of a genuine, dual protease inhibitor regimen.
"What we've got here with this combination is a safety net where patients can actually take their medications a few hours later on the weekends," Dr. Workman said. There are also no food restrictions and no additional demands for extra hydration, she added.
All studies in the Australian patient population were done on a background of combination of antiretroviral therapy, typically d4T and 3TC. In their first study, 12 patients already on two nucleoside analogues and ritonavir were switched to the dual 400 mg, twice daily, protease inhibitor combination.
"Patients had not failed any combination prior to this," Dr. Workman indicated, and viral loads on switching to the combination protease inhibitor regimen were less than 400 copies/mL. All 10 patients who reached week 36 maintained their viral loads at less than 400 copies/mL, she noted. Results on ultrasensitive HIV RNA viral assay at 52 weeks indicated that seven out of nine patients had fewer than 40 HIV RNA copies/mL--a sign, Dr. Workman suggested, that response was "both potent and durable" in this group of patients.
There were accompanying and highly significant increases in the CD4 cell count. At the same follow-up points, nine out of 12 patients had an additional rise of 100 CD4 cells, with a mean additional rise of 340 CD4 cells at the end of 52 weeks of dual protease inhibitor treatment.
Extending the experimental protocol to antiretroviral naive patients, the Australian team has treated 21 such patients with the same regimen. In this group of patients, mean viral loads prior to initiation of the combination protease inhibitor regimen were 149,000 copies/mL and the mean CD4 cell count was 400.
The investigators observed the same rapid and significant drop in HIV RNA to less than 1,000 copies/mL at week 12, and to fewer than 40 copies/mL at week 52 in 11 patients who have completed that length of treatment. Concomitant and substantial rises in the CD4 cell counts were again seen in this group of patients, where the mean increase in CD4 cell count was 425 cells by week 52--"substantially more than we would have expected to see in our practice or any practice in general," Dr. Workman added.
The group has also tested the same dual protease inhibitor regimen in heavily pre-treated and protease inhibitor-experienced patients with high viral loads prior to introduction of the ritonavir/indinavir combination. Although the numbers are still small, several patients in this salvage series now have fewer than 400 copies/mL at approximately 64 weeks after treatment was initiated.
"The bottom line for me as a clinician is that I have used no more anti-retroviral options, yet I still have patients below the level of detection," Dr. Workman commented.
Also, there appears to be no increased risk of kidney stones when the combination approach is used. Recent studies indicate that as many as one in three patients on indinavir alone are at risk of developing kidney stones some three years into treatment. In results which encompass more than 3,500 patient-weeks of treatment, "we found not a single case of kidney stones, no flank pain, and no dysuria," Dr. Workman said.
The main caveat with using the ritonavir/indinavir combination is dose escalation of ritonavir. As Dr. Workman explained, ritonavir induces its own metabolism so that if patients are given standard doses of the drug initially, drug levels end up being extremely high.
It is therefore "absolutely critical" that physicians initiate ritonavir in a dose escalation fashion: 200 mg, twice daily, for two days, followed by 300 mg, twice daily for three days, after which patients can be treated with the maximally effective dose of 400 mg, twice daily, coupled with the same dose of indinavir. (Reuters)
Advances made in detecting HIV dementia
Two brief tests for dementia in HIV-infected patients, the HIV Dementia Scale (HDS) and the Executive Interview (EXIT), show promise as brief screening tools in this population, but should not replace a complete neuropsychological assessment in patients with suspected HIV-associated dementia.
The finding comes from a comparison of the two instruments with DSM-IV (or, traditional mental illness) criteria for dementia in 103 patients with HIV/AIDS who were either hospitalized or in assisted-living environments. The subjects were predominantly male and white, with an average age of 38 years. Overall, the prevalence of DSM-IV-diagnosed dementia in this cohort was 12%. This comprised 3% of hospitalized patients and 30% of those in skilled nursing or assisted-living facilities, study director, Dr. James P. Berghuis, and colleagues at the University of Washington, Seattle, report in the June 1st issue of the Journal of Acquired Immune Deficiency Syndromes.
Cut-off scores of 10 or less for the HDS and 11 or more for the EXIT were optimal for sensitivity and specificity. Of the two screening instruments, "...the HDS was a more sensitive test for dementia, [and] the EXIT was better at correctly identifying patients without dementia," the investigators report. The EXIT also had the higher predictive value.
The individual items on the two scales that were most predictive of dementia were the HDS attention task based on "...an antisaccadic eye movement test," and the EXIT word fluency task. "However, single item tests should not be used to make a diagnosis, but only as indicators that further testing may be warranted," the authors caution.
Dr. Berghuis and colleagues also stress that the two instruments in their totality should not be used as a substitute for a complete neuropsychological assessment. However, they found the tests "...to be well tolerated even by acutely ill and significantly impaired patients, whereas a complete neuropsychological workup would have been too exhausting for many such patients."
They should have been jubilant after this year's AIDS Walk New York drew thousands of supporters to Central Park. Instead, more than 100 angry workers abandoned their desks at Gay Men's Health Crisis in protest.
"No more Lipsman service," the signs read as patients joined staffers in a tense demonstration.
Their rage was aimed at the organization's new executive director, Dr. Joshua Lipsman, a gay physician with an impeccable public health pedigree.
Lipsman has treated AIDS patients, and almost lost his last job, as public health director in Alexandria, Va., because he championed a needle-exchange program for addicts.
Yet, five months after joining the New York organization, Lipsman, 42, is the target of a deeper unease in the city's established gay community.
The nation's oldest AIDS agency is struggling with new demands to help poor and minority AIDS patients, as well as a dwindling gay white clientele still learning to live with a chronic illness.
If the protesters were confused about the future, so are Lipsman and his board as they try to adapt to the changing face of an epidemic that no longer is primarily striking gay, middle-class white men.
The immediate cause of the demonstrations against Lipsman was the new director's firing of a popular development director without explanation.
But it didn't help that the group expects a $3 million deficit next year in a $26 million budget. Or that programs such as legal aid, housing and nutrition face further cuts.
Lipsman also was criticized harshly for ordering $4,500 worth of furniture for his office his fourth day on the job.
But Lipsman's critics have stopped short of calling for his resignation. In fact, the problems at the organization are mirrored at most U.S. metropolitan AIDS agencies.
The demographics of the AIDS epidemic have shifted, with gay white men no longer contracting the disease at escalating rates. Others are, including poor Latinas in Washington Heights, intravenous drug users in the Bronx and the elderly.
One recent city Health Department study found that one in four gay black men under age 22 was infected with the human immunodeficiency virus, which causes AIDS.
There is new pressure on the organization to expand its programs to accommodate the new demographics. At the same time, donor fatigue has set in among middle-class white AIDS patients and their families. Minority patients aren't able to tap the same kind of donations, while the spending emphasis has shifted away from gay men toward women and people of color.
"The dialogue is exclusionary of gay white men, and in a lot of ways has made them the enemy," said Cornelius Baker, executive director of the National Association of People With AIDS. "GMHC needs to look at how relevant it is to the epidemic today. How expansive can its mission be?"
The idea of embracing women and minorities does not sit well with some gay white clients, who want the organization to chase off the drug addicts and newly released prison inmates who make them uneasy and scare off well-heeled donors.
"They don't have the manners, and they're uncouth," said one HIV-positive client. His solution: "Put the 'gay' back in GMHC."
Lipsman, the first physician to run the grass-roots organization, inherited near-chaos and a perception in some quarters that the organization has become a bloated quasi-government agency out of touch with its clients.
Even his critics concede that the director's job is impossible to navigate without controversy.
"We are, I believe, in a paradigm shift right now," Lipsman said. "The old ways of looking at things are no longer viable, We're in an in-between time, and an in-between time is the scariest time in the world...[particularly] if you're a front-line employee and you don't have the benefit of discussions."
Lipsman said he underestimated the fragility of the organization in his early weeks, when he bought a laptop computer and the office furniture, which has been put in storage. And he regrets those decisions.
"Let me count the ways," he said. "I must have done it in a moment of euphoria. On my fourth day, I didn't feel like it was a large amount of money."
Then, in a disastrous break with activists, Lipsman committed the organization to support the new state law requiring AIDS patients to report the names of their sexual partners.
Lipsman backed down, but the damage was done.
"They royally dropped the ball," said Eric Sawyer, a member of AIDS Coalition to Unleash Power, known as ACT UP, an activist group formed by people who felt GMHC wasn't militant enough.
Recently, Lipsman hired public relations consultant Maureen Connelly, met with employees to announce work groups in which they could talk about their concerns and brought in a financial consultant.
Yet, while the board considers a restructuring plan and staffing levels fall off in the organization's programs, clients say they are living without the critical support they expect from the agency.
"AIDS is not done with us yet," Baker said. "This virus is unrelenting in its hostility to mankind. The challenge for GMHC is, how does it sustain itself until the very end?" (New York Post)
A team of California prosecutors has sued the Rite Aid Corp., accusing the drug store chain of selling expired condoms, infant formula, contraceptives, home-pregnancy tests and other perishable products throughout California.
The civil suit was filed in Oakland after district attorneys reported finding products past their "sell by" dates on shelves in Rite Aid stores in Merced, Alameda and Santa Barbara counties and the city of San Diego. The prosecutors requested an injunction, monetary damages that could total millions of dollars and refunds for purchasers.
A spokeswoman for Rite Aid said that its company-wide policy on removing outdated products was tightened in recent months after the prosecutors complained.
"We're diligently working to make sure that it's a top priority," said public relations manager Sarah Datz. She said Rite Aid was "surprised and disappointed" at being sued despite cooperating with the prosecutors.
But Anthony Douglas, a deputy district attorney in Alameda County, said outdated infant formula was being sold as recently as the day the suit was filed in a Rite Aid store in the Contra Costa County town of Lafayette. Rite Aid has more than 600 stores in California.
Formula manufacturers warn that outdated cans must be discarded because the product loses nutritional value and may deteriorate in other ways. Some of the other products, such as condoms and spermicides, may become ineffective in protecting users against sexually transmitted diseases and unwanted pregnancies.
Larry Morse, the chief deputy in the Merced County District Attorney's Office, which initiated the investigation, said the prosecutors had no information about injuries to consumers but could uncover some during the course of the lawsuit. The prosecutors set up a hot line -- (800) 869-9824 -- for consumers to report sales of expired health products by Rite Aid or other retailers, as well as injuries from the products.
Morse said the case was developed after a consumer complained to his office about expired infant formula in a Rite Aid store. An investigation discovered the problem was "pervasive" in Merced County, he said. The other jurisdictions were sampled to determine whether the whole state was affected, he said.
The consumer and environmental protection unit in the Sacramento County District Attorney's Office has received no such complaints about Rite Aid, and a check of some stores in the capital area turned up nothing, said Scott Prentice, unit supervisor.
Datz said Rite Aid had long had a practice of removing perishable products 30 days before their expiration dates but changed the policy last month to remove them 60 days in advance. She said store managers are trained to do so and are reminded frequently.
She was unaware of the problem reported in the Lafayette store but said the company would look into it. On March 12, Rite Aid corporate counsel Michael C. Fox wrote a letter to Merced County District Attorney James Swanson, saying that no expired infant formula had been sold in the company's California stores since Feb. 26. However, Swanson said the problem persisted.
Rite Aid, based in Camp Hill, Pa., is the nation's third-largest drugstore chain with more than 3,800 stores nationwide.
"What is most astounding and disconcerting is that Rite Aid did not alert their customers" even as "they bragged in commercials'' that customers were the key to their success, Merced County District Attorney Gordon Spencer said.
Karen Rugen, a Rite Aid spokeswoman, said the company also posted signs advising customers that if they purchased expired infant formula, it would be replaced with fresh formula free of charge.
Prosecutors said the outdated items include the baby formulas Enfamil low iron, Enfamil LactoFree and Similac with iron; Ramses, Lifestyle and Sheik condoms; Advil; Clear Blue Easy pregnancy tests; and Ortho-Gynol spermicidal jelly. (Sacramento Bee, Associated Press)
The Africa Growth and Opportunity Act, or as ACT UP's Paul Davis calls it, "the AIDS Growth and Opportunistic Infections Act (AGOA), has reappeared on the agenda of the U.S. Congress and is being prepared for a floor vote, according to Davis.
Broad coalitions of activists handed the bill a serious setback last month with sign on letters, lobby visits, and a thousand person demonstration and civil disobedience at the Pharmaceutical Manufacturers Association. Davis says the bill "seemed derailed, but is now being quietly fast tracked by the Clinton/Gore Administration."
Davis said the bill may hit the house floor sometime in June.
AGOA would reduce spending on health and education in developing nations in Africa.
"AGOA does not protect nations manufacturing generic versions of critical medications from trade sanctions," Davis said. "AGOA does not restore funding to international health programs. Jesse Jackson Jr.'s HOPE for Africa Act does."
"AGOA only increases suffering and death in Africa by requiring that nations comply with IMF-style development policies that increase starvation, infant mortality rates, and AIDS," Davis continued. "In exchange for complying with these onerous restrictions, garment manufacturers running sweat shops in Sub-Saharan nations will receive trade preferences that destabilize the U.S. textile industry. African residents will not benefit from the alleged bonuses. Most of the increased trade dollars will leave the original country--after local governments take their piece.
"The HOPE for Africa Act would stop the U.S. from punishing nations like South Africa for its efforts to manufacture DDI, AZT, or other inexpensive to manufacture drugs. The cost in lives is millions."
Davis calls on activists to contact their representatives in Congress and ask them to vote against the Africa Growth and Opportunities Act, and instead to support the HOPE for Africa Act. Members of the House can be reached through the Congressional switchboard at 202-224-3121.
AF-AIDS discussion group
People interested in keeping up with issues related to AIDS and Africa can sign up for AF-AIDS, an email discussion forum on HIV & AIDS in Africa Discussion and exchange of information and experiences has recently begun on AF-AIDS - a new regional HIV/AIDS information email forum for Africa (in English and French). Over 1200 people and organizations working in or with African Nations in the response to the epidemic have already joined the forum.
Each day members discuss current HIV/AIDS issues and share their experiences about what works and what does not in response to the epidemic, as well as news from the regions and forthcoming events such as conferences and workshops. The forum is also linked to a similar initiative among over 1600 people working on HIV in Asia, so that the two regions can benefit from each others experience and knowledge.
You can join AF-AIDS by sending an email to: with the word 'join' in the subject line. You will automatically be sent each days messages free of charge. Or if you have full internet access, you can point your web browser to: http://www.hivnet.ch:8000/af-aids/tdm.
The AIDS Project, a nonprofit, independent organization located in State College, Pennsylvania, is currently searching for an Executive Director.
The Executive Director is responsible for financial and personnel management, public relations, and general agency administration. Experience with grant writing, fundraising, and development required. Knowledge of HIV/AIDS and experience working with diverse populations preferred. The ability to build bridges between a variety of groups - including rural and University communities - is required.
Starting salary for the position is in the mid-30s, commensurate with experience, along with a benefits package. A bachelor's degree is required.
Applicants are asked to send a cover letter and resume by June 28, 1999, to: Search Committee, The AIDS Project, 315 South Allen Street, Suite 116, State College, PA 16801.