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Issue #165: February 22, 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 information in this issue include Clinical Infectious Diseases, Journal of the American Dental Association, Philadelphia Gay News, Postnet Online, Reuters, Wall Street Journal.Ridge plans extra charge for SSI checks
City sets forums on HIV reporting
Short-course AZT prevents vertical transmission
HIV specialists mean longer survival: study
FDA issues warning on Hismanal
Cavities linked to thrush in PWAs
Ridge plans extra charge for SSI checks
Pennsylvania State Senator Vincent Fumo has asked the Ridge Administration to withdraw its proposal to charge poor disabled, aged and blind and people another $2.60 per month to process their federal Supplemental Security Income (SSI) checks.The additional charge, if implemented, would increase the total deduction to $7.60 per month, meaning the state would be keeping nearly one-fourth of the $32.40 monthly state SSI supplement.
There are about 270,000 SSI recipients in Pennsylvania, all of whom are poor and most of whom (about 219,000) are disabled. About 12,000 of the disabled are those who receive SSI because they have HIV disease.
Fumo called attention to the issue in the monthly Senate Democratic caucus radio address. In that address, he pointed out that especially while the state is running huge budget surpluses, there is no need for Governor Tom Ridge to squeeze the meager income of the poor.
"While the state sits on hundreds of million of dollars, he wants to charge aged, blind and disabled people another $2.60 per month to process their federal SSI checks -- money that comes directly from the pockets of people who need it most," Fumo said in the radio speech.
The state provides a supplement to the federal SSI payment, which is added onto the check sent to recipients. When the federal government began charging states for the processing of the state supplement, the administration of former Gov. Robert Casey at first absorbed the charge.
When the federal government increased the charge to $5, however, Casey said the state could do it more cheaply by sending out its own checks.
The Ridge Administration reversed that decision and in January 1996 began charging SSI recipients a monthly charge of $5, which was subtracted from their payment. The federal government now proposes to increase the charge to $7.60 next January, and the Ridge Administration wants to pass that levy on to the recipient.
"As we have seen many times in the past from this governor, the new budget contains another attack on the most vulnerable of Pennsylvania's citizens," Fumo said. "This amounts to a tax on being poor and disabled.
"There is no mandate that the state pass this charge through."
The declining SSI support for poor elderly people comes at the same time the Ridge Administration is refusing to expand eligibility for the Pharmaceutical Assistance Contract for the Elderly (PACE), Fumo noted. The creation of a second tier of eligibility last year for senior citizens who are slightly over the regular income limits has been a failure, resulting in far fewer people enrolling than expected. Those in the second tier must meet a $500 annual deductible and make a higher co-payment on each prescription.
Many Democrats have called on the administration to abolish the second tier and raise the maximum PACE income levels to allow more seniors to benefit.
City sets forums on HIV reporting; Illinois joins trend
The Health Department's AIDS Activities Coordinating Office will hold two public meetings on March 11th and 18th to hear views on whether or not to require that doctors, laboratories and hospitals report individuals who test positive for HIV.Both meetings will be held at 6 p.m. at Health Center 1 at Broad and Lombard Streets. Individuals and organizations wishing to present testimony at the forums are asked to call 685-6789 to register.
The issue of HIV reporting has become more important in recent months as the U.S. Centers for Disease Control (CDC) has asked states to begin planning to require the reports.
To date, 31 states, including New Jersey, have HIV infection reporting systems. In Pennsylvania, only a formal diagnosis of AIDS is currently reportable to public health authorities.
Pennsylvania health department officials are still weighing the pros and cons of requiring HIV reports, as well as whether the reports would be made with the names of those infected or a code to protect their identities. Harrisburg's decision on these issues will be applicable to all local health departments in the state, including Philadelphia's.
The CDC says that, with new advancements in the treatment of HIV disease which have significantly lowered death rates and improved the quality of life for thousands of people with HIV/AIDS, the reporting of HIV infections to public health authorities will not only lead to better projections of the extent of the HIV/AIDS epidemic, but result in more HIV-positive people being able to access new drugs and quality health services. A more accurate count of those who are infected with HIV might also lead to more federal resources being allocated to fight the epidemic in the state.
The CDC's Dr. Kevin DeCock said late last year that he expects a national HIV surveillance system to be in place possibly by this summer and no later than the beginning of 1999.
In recent months, the CDC has been very active and vocal about the need to change policies in the 20 states that have resisted HIV reporting measures, holding seminars and meetings aimed at influencing public health and community leaders.
Many advocates, however, have criticized HIV reporting, saying that it may discourage those most likely to be infected from seeking testing because they are afraid their confidentiality may be violated. They have also criticized the claim that reporting would result in better medical care, unless significantly increased funding is allocated for AIDS care. Still others have generally supported the concept of HIV reporting, while opposing the reporting of names in favor of a "unique identifier" code that would keep the individual's identity from appearing on government reports and databases.
Some critics assert that name reporting could lead to discriminatory actions. Norma Lopez, of the National Council of La Raza in Washington, D.C, states that "there is no question in [her] mind that name-based surveillance will be used against immigrants in this country."
Anna Forbes, a longtime advocate for the use of "unique identifiers" rather than names in the reporting of epidemiological information on people with AIDS, told the Philadelphia Gay News last week that "everybody is going to have to make some compromises. The advocates may not get all the privacy protections they want. And the Health Department may not be able to collect as much HIV data as it would like."
She said that "we have to get to the point where everybody says, 'ok, this is the bargain we've struck."
State health department spokesman said that the Commonwealth has not yet formalized a position on the method through which HIV reporting should be conducted, although the reporting itself is inevitable. He said that Philadelphia may be able to develop its own coding system, unless the state requires all local health departments to begin reporting names.
"The issues are HIV reporting are complex and serious," said Joe Cronauer, co-director of the city's AIDS office, in announcing the public forums. "We think it's important that Philadelphians who care about this issue have an opportunity to talk to us about their perspectives on this issue as we prepare to advise the state in developing its policy."
Illinois joins name reporting trend
Meanwhile, Illinois Department of Health head John Lumpkin has announced that the state will institute mandatory name reporting for people who test positive for HIV. The state already requires name reporting for 60 other infectious diseases, including tuberculosis, syphilis, and gonorrhea.In response to critics who argue that mandatory name reporting could discourage people from getting tested for HIV, Lumpkin said that "we have carefully studied the issue of name reporting for two years and believe the time has come to treat HIV like other sexually transmitted diseases." The new requirement, which will take effect in 90 to 120 days, will also link HIV-positive individuals with health care services to ensure follow-up treatment, he said.
Illinois is the 31st U.S. state to require name reporting of HIV-infected individuals.
Short-course AZT prevents vertical transmission
A short-course regimen of zidovudine (AZT) administered to HIV-positive women in late pregnancy and during delivery reduces the rate of vertical transmission by 51%, according to the results of a clinical trial in Thailand.The preliminary results of the trial, which is sponsored by the Centers for Disease Control and Prevention and UNAIDS, was announced by the Ministry of Public Health of Thailand.
The findings offer hope to many developing countries that have had no therapeutic options to prevent vertical infection of HIV, the Ministry said. "Now we are a step closer to seeing the kind of progress that we've made at home extended to the developing world," HHS Secretary Donna E. Shalala said.
Investigation of the safety and efficacy of a short-course regimen began following the recommendation of an international panel that met in Geneva in June 1994, according to CDC officials. This panel "..called for the exploration of alternative regimens that could be used in the developing or newly developed world, [and stated] that logistical issues and costs would preclude the worldwide application of the longer regimen." It is estimated that the longer zidovudine regimen costs at least $800, which is about 80 times the annual per capita health budget in many developing nations.
"We've shown very conclusively that the short-course AZT regimen is pretty effective -- we were able to reduce transmission by half, which is very good," Dr. Martha Rogers, who is the Associate Director for Science at the CDC's Division of HIV/AIDS Prevention, said. "And I think now the challenge that really exists is how do we take what we found in the clinical trial and put that into practice in the developing world."
Having the data from this "very rigorously" done clinical trial is very useful when approaching donor agencies for the resources to put this intervention into effect, she continued. However, this intervention "...is still beyond the means of many countries, and it will take a great deal of effort -- of both resources and technical support--from the developed world in order to put this in place in the developing world."
The trial included 397 pregnant HIV-positive women who were randomized to a short-course of AZT or placebo. Results were based on the 391 infants born to these women, Dr. Rogers continued. The subjects in the treatment arm received 2 to 4 weeks of AZT, beginning treatment at approximately 36 weeks gestation. A 300-mg tablet of AZT was given twice a day, instead of 5 times a day as in the longer US trial. Also, during delivery, instead of an intravenous dosage of AZT, the women were given pills, which they took about every 3 hours while they were in labor. No treatment was given after delivery and none of the infants were treated.
In a joint statement, officials at UNAIDS, the National Institutes of Health and the Agence Nationale de Recherches sur le SIDA (ANRS) called these findings "...an important step forward in international efforts to develop interventions that can be broadly and safely implemented and which, more specifically, can respond to the requirements of many developing countries."
The data are now being shared with collaborators and the sponsoring organizations, and study sponsors "...have recommended to the principal investigators of clinical trials currently sponsored by these agencies that placebo arms be dropped or replaced with the CDC short-course regimen."
"A number of the trials that have been conducted, including the CDC-supported trial in Thailand, have included a placebo arm. Use of a placebo arm was the only way in which it could be clearly and quickly established whether a shorter AZT regimen was safe and more effective than no treatment at all, since previously these data were unavailable," the joint statement continued. Many advocates criticized the use of placebos in the trial, saying that it denied women and children access to a treatment that earlier evidence had already shown would likely be more effective.
In March, UNAIDS plans to host a meeting in Geneva for international agencies and governments from developing counties to identify "...ways of rapidly and effectively implementing the results of this and other trials into public health policy as they become known."
HIV specialists mean longer survival: study
HIV-positive people are more likely to survive longer if they receive treatment from an AIDS specialist rather than a primary care physician, according to a position statement from the Infectious Disease Society of America (IDSA) that appears in the February issue of Clinical Infectious Diseases.The position paper was released as Pennsylvania Welfare Dept. officials continue to resist pressure to make it easier for Medicaid recipients living with HIV/AIDS to obtain their care from AIDS specialists. Medicaid managed care organizations in southeastern Pennsylvania have refused to publish their own lists of AIDS specialists to make it easier for Medicaid recipients to identify them, and the state has consistently refused to raise reimbursement rates for more expensive AIDS specialty care.
City health officials have also recently reduced funding for AIDS specialty clinics in a variety of sites throughout the city, citing growing pressure on the limited federal resources allocated for AIDS services in the region.
There have recently been rapid and dramatic changes in HIV treatment, Dr. Daniel J. Sexton of Duke University in Durham, North Carolina and members of the Clinical Affairs Committee explained in their statement. "For example, combination therapy for HIV infection became the standard of care for patients with AIDS in the United States at least 6 months before the first papers demonstrating the effectiveness of such care were published in peer review journals." It is also likely that in the upcoming months and years that there will be more changes in the treatment of HIV infection.
Studies have also shown the primary care physicians are slower to adopt new HIV treatment strategies. The results of one study indicated that primary care physicians "...lagged 3 years behind AIDS specialists when the proportion of patients receiving antiretroviral therapy within 6 months of an AIDS diagnosis was used as an outcome." Similar gaps in the optimal use
of prophylactic therapies for opportunistic infections are also evident.
Dr. Sexton's group points to "...an increasing amount of data showing that survival of patients with HIV infection is prolonged if these patients are cared for by physicians who are experienced in the management of HIV infection."
Other studies show that AIDS experts are more likely to provide cost-effective care to HIV-positive people because of, for example, better selection of antiretroviral drugs and more timely recognition and treatment of patient complications. Treatment by an AIDS expert can reduce the number of inpatient stays and office visits.
IDSA members believe that "[h]ealth care systems that restrict access of HIV-infected patients to infectious diseases specialists or to other physicians who are truly experienced in the management HIV disease may actually experience increased cost, increased risk of complications, and increased mortality."
FDA issues warning on Hismanal
The U.S. Food and Drug Administration has issued a warning about drug interactions and adverse events associated with the antihistamine astemizole, marketed as Hismanal by Janssen Pharmaceuticals.According to an FDA Talk Paper, Janssen has made labeling changes to the drug to include warnings about risks of death due to irregular heart rhythms and rare events of anaphylaxis when Hismanal is taken with certain other drugs and at higher than recommended doses. The drug's label already carried a warning against using Hismanal with the antihypertensive mibefradil dihydrochloride (Posicor) and the antibiotics clarithromycin (Biaxin) and troleandomycin (TAO).
The label changes include warnings against using Hismanal with the HIV protease inhibitors indinavir (Crixivan), ritonavir (Norvir), saquinavir (Invirase), and nelfinavir (Viracept); the serotonin reuptake inhibitors fluoxetine (Prozac), fluvoxamine (Luvox), sertraline (Zoloft), nefazodone (Serzone), and paroxetine (Paxil); and the anti-asthma drug zileuton (Zyflo).
In addition, the label warns against taking the drug with grapefruit juice or if the patient has liver problems.
Peter Honig, a medical officer with the FDA's pulmonary drug products division, said that "A lot of this information was already available. In making this announcement, we want to make the information more up-to-date and comprehensive."
Last year, Hoechst Marion Roussel withdrew its antihistamine, Seldane, from the market because of irregular heartbeats and other potentially fatal adverse events associated with the drug. Pamela Rasmussen, a spokeswoman for Janssen, which is a unit of Johnson & Johnson, said that the drug is "chemically different from Seldane," and added that the FDA hadn't suggested the company remove the product from the market.
Cavities linked to thrush in PWAs
Cavities in the teeth of HIV-positive patients can serve as reservoirs for fungal organisms in the mouths of these patients, according to a study in the February issue of the Journal of the American Dental Association.Treating cavities could help cut the risk of fungal infections in these patients, according to the study.
Researchers at the University of Texas studied extracted teeth from HIV-positive and HIV-negative people to check for candidiasis and its manifestations. Among their findings, they report that the infection was found in 77% of the HIV-infected group compared with 17% of the HIV-negative group.
"We found that when individuals have deep cavities, a number of bacteria will reside in these cavities," one of the researchers, Dr. Catherine M. Flaitz, said. "We also found that fungus was very predominant in the majority of our patients that had HIV infection. That's important, because we know that these fungus infections, or candidiasis, are a common oral manifestation of HIV infection."
In some cases, these oral infections are very difficult to treat and they keep coming back, she explained. "If you don't treat the whole disease, including the potential niches for this fungus, it will temporarily respond to treatment but recur over and over again."
Flaitz recommended placing fillings in teeth or removing teeth that cannot be restored. Patients who are prone to getting deep cavities should use fluoride and better brushing techniques to reduce their risk of recurrent fungal infections.
"A number of (HIV-positive) patients are on medications that cause dry mouth, and when you have dry mouth you are more prone to developing cavities, especially by the gum line because you don't get the self-cleansing action of saliva," Flaitz said. "Also, a number of the medications and mouth rinses used to treat fungus infections actually have a high sugar content, and that certainly would be something that would promote cavities, especially if a person has dry mouth."
Penn seeks HIV care manager
The University of Pennsylvania Health System is seeking a "care manager" to help coordinate services for patients with HIV/AIDS.Responsibilities would include coordination of medical care as well as patient education and counseling. The care manager serves as a liaison between the Primary Care Physicians and the HIV clinic at the University's medical center.
Requirements include HIV experience and a health background in nursing or social work. Interested parties should send their resumes to Sherry Marcantonio, Office of Disease Management, 1 Wright-Saunders Administration, 3900 Market Street, Philadelphia, PA 19104.
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