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Issue #179: May 31, 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 wtp@critpath.org and type the message SUBSCRIBE in the message section. Sources for some articles in this issue include Reuters and San Francisco General Hospital.City asks state for more study on HIV reports
"Rite Aid lied," protesters say
Clinical trial on marijuana begins among PWAs
Council set to debate sidewalk ordinance
Project HOPE seeks peer educators
WTP's Lee Mathis gets American Cities Award
City asks state for more study on HIV reports
Philadelphia health commissioner Estelle Richman has called on state officials to delay implementing a new requirement that new diagnoses of HIV infection be reported by name, after reviewing the input from over 40 community representatives who testified at two public forums held in Philadelphia in March.In a letter to the state health department, Richman noted that none of those participating in the forum, which includes people living with HIV/AIDS, medical and social service providers, and community representatives, opposed in principle the concept of HIV reporting, but that all were vehement in opposing the use of names in keeping government records on HIV infection.
A majority of the states now require HIV reporting by name, with only two experimenting with using what are called "unique identifiers" to catalog those diagnosed with HIV. All states, including Pennsylvania, have reported diagnoses of AIDS with names since 1981.
Pennsylvania health officials are being asked by the federal U.S. Centers for Disease Control and Prevention (CDC) to implement an HIV reporting policy as soon as possible. The CDC says that with improved treatments for AIDS, counting only those who are formally diagnosed with AIDS no longer provides an accurate reflection of the extent of the HIV epidemic.
Government officials and many leaders of AIDS service organizations are also concerned that future federal funding for AIDS services will be based on how well a community is doing in tracking actual HIV infection, as opposed to making projections on the prevalence of HIV on the basis of the numbers of people with AIDS.
In a 30-page report submitted to state health secretary Daniel Hoffman, the city health department detailed the local debate on the HIV reporting issue and called on the state to "consider seriously the perspectives represented in this document in its considerations on the advisability of changing Commonwealth policy with regard to the reporting of HIV infection." In a cover letter, Richman strongly emphasized the almost universal local opposition to HIV name reporting, and asked that the state hold further hearings across the state to gauge public opinion prior to making any change in its regulations. Знаем секреты. Лучшая раскрутка сайтов продвижение украина.
Under state law, regulations on the reporting of infectious and contagious diseases are a state responsibility, and the city is required to institute any policies developed on the state level. The policy can be changed administratively, which means it does not need to go to the state legislature for approval.
Governor Ridge, who is campaigning for re-election this year, pledged in his first campaign to oppose name reporting for HIV infection, but has not commented on the issue this year.
In its report on the two public forums held in March, the city also transmitted to the state excerpts from the testimony of many of those who participated, as well as a statement from 36 organizations serving people with AIDS opposing name reporting.
Richman declined to follow the suggestion of many advocates at the hearing that the city health department formally oppose name reporting in favor of a "unique identifier" system. However, while the report on the forum attempted to cover arguments both for and against name reporting, in her cover letter, Richman encouraged the state to "seriously consider" alternatives to name reporting if it expects the new policy to be effective.
"Rite Aid lied," protesters say
People living with HIV/AIDS and representatives of most major AIDS service organizations in the region conducted an angry protest outside a center city Rite Aid pharmacy this week, claiming that the region's dominant drugstore chain has reneged on commitments it made to make AIDS-related prescriptions more available to its customers living with HIV/AIDS.Rite Aid officials have held several meetings with representatives of the HealthChoices AIDS Working Group and the AIDS Law Project of Pennsylvania to hear complaints that many people with HIV/AIDS have been unable to obtain routine AIDS medications, including protease inhibitors, from the chain's stores. People who are insured through HealthChoices, the state's new Medicaid managed care program, which covers about 70% of PWAs in the Philadelphia area, have reported that many Rite Aid pharmacies appear unaware of or reluctant to use state programs which supposedly guarantee access to the drugs. For you magento template tutorial.
Despite Rite Aid commitments that new procedures would be in place by May 1st to guarantee speedy access to medications, the Community AIDS Hotline (215-985-AIDS) has reported that it continues to receive complaints from PWAs that they are being referred by Rite Aid pharmacists to other pharmacies or are forced to wait for several days before their prescriptions can be filled. Rite Aid officials had guaranteed that each pharmacy would have an adequate stock of the medications, and that emergency procedures were in effect to assure immediate access to the drugs if a drug was unexpectedly out of stock.
Some consumers have reported that their pharmacists do not seem to know how to contact the Rite Aid officials who are supposed to be monitoring the effort to improve access, and refuse or are reluctant to use state computer networks to confirm their eligibility. One consumer reported to the Working Group that he was told "thank you for nothing and don't come back" by a pharmacist at Rite Aid's Broad Street store, where the protest was held, and that people with HIV/AIDS are routinely made to feel unwelcome at Rite Aid pharmacies.
Rite Aid, which through a subsidiary manages the prescription program for the largest of the HealthChoices managed care companies, Keystone/Mercy Health Plan, has been under attack for significantly reducing reimbursement for prescription drugs for pharmacies serving Keystone clients. As a result of the reduction in payments for prescriptions, many area pharmacies now refuse to honor Keystone prescriptions.
Unimed drops NTZ studies
Unimed Pharmaceuticals has formally announced that it will cease its efforts to investigate the effectiveness of NTZ (Nitazoxanide, marketed as Cryptaz) in treating people living with AIDS who have diarrhea related to infection with cryptosporidium parvum, a bacteria sometimes found in common drinking water.Based on data from three clinical trials that involved a total of 226 patients with AIDS plus 2 other patients with severe immune deficiencies of other causes (most of whom had T-cell counts of 50 or less), Unimed Pharmaceuticals had asked that the U.S. Food and Drug Administration earlier this month to approve the drug for accelerated approval.
An FDA committee recommended against the request, saying that further testing was needed.
"Crypto is often present in low levels in water supplies and can be transmitted through contaminated food and through sexual contact," according to AIDS treatment activist Bob Roehr. "It is little more than a minor irritant for most people but can be deadly for people with compromised immune systems."
The effect of crypto on people with AIDS was dramatized several years ago after a major outbreak in Milwaukee in 1993 sent 4,500 to the hospital and killed 110, mainly people with AIDS. In Philadelphia, the discovery by city officials of high levels of crypto in some samples of city drinking water led the city's AIDS Activities Coordinating Office (AACO) to issue an alert to local people with AIDS, as well as more formal efforts to keep records on those diagnosed with AIDS-related cryptosporidiosis.
Since 1990, the city has seen 156 cases of the diagnosis, according to AACO, but the incidence has dropped dramatically over the past two years, possibly because more PWAs are using three-drug combinations that have improved their immune response overall. So far this year, only six diagnoses of AIDS-related cryptosporidiosis have been reported, compared to eleven for a similar period last year.
Many people with AIDS have learned to rely more on bottled water than on tap water for basic tasks like drinking and showering, in order to reduce their exposure to crypto.
There is no effective treatment for crypto on the market, and there were hopes that NTZ would prove effective against the drug. People with AIDS have been able to obtain the drug through buyer's clubs from sources in Mexico, although some shipments were held up by federal officials several years ago because the drug was unapproved.
According to Unimed, their trials showed that treatment resulted in a 50% reduction in stool frequency in about 40% of patients with AIDS. "Given the severity of the disease and the lack of effective treatments, this is a relatively promising response rate," Unimed officials said.
In addition to a reduction in severity of diarrhea, patients in the 3 studies reported reductions in nausea, abdominal cramping and pain, fecal incontinence, rectal pain and sleep disturbance secondary to frequent bowel movements. Long-term data show that treatment may reduce the amount of Cryptosporidium parvum in stools, according to Unimed's press release.
However, many treatment activists say that while the Unimed drug is probably safe, they were not impressed by the company's efforts to show that it was particularly effective.
According to Roehr, "The advisory panel, patient advocates, and FDA officials seemed to be bending over backwards to try to find a way to recommend approval of the drug, but in the end the panel voted 10-1 against that."
"The scientific gold standard for approval is a double blind placebo control trial. Many question whether it is even ethical to pursue a placebo trial in such a profoundly ill population," Roehr noted.
There are also practical concerns, Roehr said. "Protease inhibitors have kept people healthy enough to avoid many opportunistic infections such as crypto. And Cryptaz, which has been approved for use in Mexico, is widely available through buyers clubs, though third party payers will seldom cover the cost."
Those two factors have so greatly reduced the pool of patients that a clinical trail (ACTG 336) was able to enroll only 10 of the 60 people it was designed to follow. The trial was closed down on May 15.
In a statement issued a week after the FDA decision, Unimed said that "the lack of a suitable patient population in which to conduct the type of studies requested by the FDA's Antiviral Advisory Committee" led to their decision to stop their studies on the utility of NTZ for AIDS-related diarrhea.
"Unimed was reduced to doing historical comparisons with the data it had," Roehr said, "much of it from the pre-protease era. Cryptaz appears to have worked well in a few patients, even clearing the parasite from them, but overall the data showed no significant statistical difference from placebo. The committee offered suggestions on how the company might conduct in depth examination of a small number of patients and then reanalyze their data to perhaps determine a subset of patients and conditions in which the product might achieve better results."
In deciding not to pursue approval for NTZ, Unimed said that the numbers of people with AIDS affected by cryptosporidial diarrhea was dropping as a result of new antiretroviral therapies, and that its market for the drug in the U.S. was undercut by the relatively easy availability of "unapproved" NTZ from Mexico. It estimated the total number of American PWAs who would need the treatment to be "less than 4,000 individuals."
"As a result, finding suitable patients to allow for the highly controlled studies called for by the committee has become all but impossible. Additionally, other considerations arise in asking patients to risk 'non-treatment' should they fall into the placebo arm of such studies."
Unimed will continue its investigations into the use of NTZ for other indications besides AIDS, the company said, "which also have much larger target patient populations."
Unimed said it will continue to provide NTZ to people with AIDS who are receiving it through their "compassionate use" program "for as long as deemed appropriate by their physicians."
However, no new patients will be treated under the current protocol.
Clinical trial on marijuana begins among PWAs
A two-year clinical trial to assess the effects of marijuana on the immune system and the viral load of HIV-positive people began this month in San Francisco, according to a joint press release issued by the San Francisco General Hospital Medical Center and the University of California.The study is also examining potential interactions between marijuana and protease inhibitors as well as other drugs commonly taken by people living with HIV disease.
UCSF researchers and the Community Consortium received approval for the trial, called "Short Term Effects of Cannabinoids in HIV Patients," from the National Institutes of Health last fall. A total of 63 patients taking indinavir or nelfinavir will be housed at the General Clinical Research Center at SFGH for 25 days for careful monitoring. The subjects will be given marijuana to smoke, Marinol in oral tablet form (which contains THC), or placebo.
"Our main goal is [to] find out what is safe for HIV/AIDS patients," Dr. Donald I. Abrams, principal investigator explains. "We know many patients use marijuana to relieve nausea and loss of appetite brought on by the disease and its treatments, but we don't know how THC -- the active ingredient in marijuana -- interacts with HIV drug therapies."
In particular, Dr. Abrams' team will be looking at the effects of THC on protease inhibitor metabolism to see if THC alters plasma concentrations of the drug or increases toxicity. Along with THC and protease inhibitor pharmacokinetics, the investigators will examine the effects on THC on weight, appetite and hormone levels, in particular testosterone.
Council set to debate sidewalk ordinance
Philadelphia City Council has set public hearings on what Council President John Street called a"Sidewalk Control" ordinance, aimed at reducing the numbers of homeless people in public spaces and connecting them with long-term services.The public hearing is scheduled for Wednesday, JUNE 3 at 9:00 A.M. in Room 400 of City Hall.
The Open Door Coalition, a collaboration among organizations which serve the homeless and homeless advocates, has vigorously opposed the ordinance, which it says unfairly targets homeless people with prohibitions against lying down, sitting in public spaces, and aggressive panhandling.
"This hearing is a critical opportunity to send our message to City Council: do not punish or criminalize persons who are homeless," the Coalition said in a statement. "Instead, let's develop real solutions to homelessness."
While continuing to organize against the ordinance, groups belonging to the Coalition have also been working with city officials to guarantee that outreach, housing and social services are available to those who would be arrested or referred under its provisions if it gets passed. Most observers believe that Council President Street, the measure's main sponsor, has the votes to pass the legislation unless there is increased public outcry.
The Coalition hopes to dramatize community opposition to the bill through a large turnout at the June 3rd hearing.
For more information, contact Will O'Brien or Peter Gonzales at Project H.O.M.E., 215-232-7272; email HN5672@handsnet.org.
Project HOPE seeks peer educators
Montgomery County's Project HOPE is seeking peer educators to join its successful HIV outreach/harm reduction team. Activities of the team include street, park and drug use site outreach and also prevention education in drug and alcohol facilities and community drop in facilities through out Montgomery County. Team members provide counseling and testing using the OraSure testing method. Project HOPE is the only HIV prevention education program in Pennsylvania using OraSure on the street outreach level. Team members concentrate counseling and testing on high-risk individuals only.Project HOPE will provide training and certification as a prevention education specialist through cooperation with the State Department of Health. Project HOPE will provide orientation to community based sites and identifying clothing. Some compensation is available as is reimbursement for mileage. Public transportation throughout the county is very limited.
Applicants must be 18+, drug and alcohol free or in recovery program for at least one year. Persons who are HIV+ are especially encouraged to call for more information. Project HOPE also seeks team members who speak Spanish, Korean or other Asian, Indian or Pakistani languages.
Project HOPE is a project of Family Services of Montgomery County, a Pennsylvania non-profit corporation. Project HOPE is a diverse organization providing case management services since 1989.
For more information contact Ada Wilson, Prevention Education Specialist. 610-272-1520. FAX a letter of interest to 610-277-3784 or e-mail to projhope@voicenet.com.
WTP's Lee Mathis gets American Cities Award
We The People housing counselor Lee Mathis will be honored at the Sixth Annual Men Making a Difference conference, sponsored by the American Cities Foundation, for his work on behalf of people living with HIV/AIDS.U.S. Rep. Chaka Fattah, the chair of the meeting's selection committee, said that the event is aimed at honoring "African American men who are making significant contributions to our community." He said that Mathis and others who will receive recognition at the event provide "an opportunity for young African American men to witness, experience, and be inspired by these same individuals who are making a difference."
Mathis has been a housing counselor at We The People since last year, and previously served for several years as coordinator of Life Center services. He has also worked as an independent AIDS case manager.
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