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Issue #240: July 30, 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:
New state rules endanger Title II services
MDs discriminate against some PWAs in offering HAART
HIV+ women have lower prenatal care rates
Koop urges support of needle exchange
Jackson won't drop African drug fight
MDs still need basic HIV management skills
Study finds pill coating kills HIV
Names reporting called deterrent to testing
Jackson won't drop African drug fight
New state regulations requiring prior state review of contracts issued by The Philadelphia AIDS Consortium (TPAC) have led to such long delays that most agencies have been working for a month without a contract.
A number of TPAC-funded agencies have announced that they might be forced to layoff workers or cut back services unless the delays are overcome.
The changes were made by the state legislature to require that agencies like TPAC, which distributes Title II Ryan White CARE ACT and state AIDS education funds in the five-county southeastern Pennsylvania area, must submit their subcontracts to the state prior to issuing them to service providers. According to sources, the state now requires prior approval of the sub-contract language, budgets, work plans, and appendices for each sub-contract prior to distribution to service providers.
At a meeting with Title II providers earlier this week, TPAC staff said that the delays in Harrisburg in approving the sub-contracts mean that providers will not be reimbursed for services delivered in July until at least October - and that's only if TPAC experiences no additional delays in getting the cash from the state. In effect, AIDS agencies will be asked to operate out of savings and loans - which many don't have and can't qualify for - or by using funds received from other government agencies for the state-funded services, a technical violation of the law.
TPAC's state funds are the major source of funding for AIDS services in Philadelphia's suburbs. For some suburban agencies, TPAC is the only funding source, and it's those agencies that are most likely to have to layoff staff or curtail operations.
Agency representatives noted at the meeting that in addition to the reduction in client services, if staff is laid off their contracts will be under-spent and service goals may not be achieved. In effect, they said, the state's own delays in approval and payment will force them to violate the terms of the contracts that are currently being reviewed.
The major providers who may be affected by the problem include AIDS Services in Asian Communities, the AIDS Care Group, Family Services of Montgomery County, Family and Community Services of Delaware County, ActionAIDS, American Red Cross, the Maternity Care Coalition, the Southeast Asian Advocacy Mutual AIDS Assistance Coalition, Philadelphia Health Management Corporation, We The People, and Chester County AIDS Support Services. Other groups affected include St. Mary's Respite Center, West End Medical Association, Family Service of Bucks County, Family Service of Chester County, Colours, the Jonathan Lax Immune Disorders Treatment Center, North Philadelphia Health Systems, the Circle of Care, and Keystone Crozer Medical Center.
Agencies funded by TPAC are contacting their elected representatives and state health department in an effort to break the logjam.
MDs discriminate against some PWAs in offering HAART
Despite high viral loads, HIV-infected patients with a history of depression or injection drug use, and those with higher CD4 cell counts, have "significant and lengthy delays" in receiving protease inhibitor therapy.
Dr. Kathleen M. Fairfield, of the Beth Israel Deaconess Medical Center in Boston and colleagues conducted a chart review of 190 HIV-infected patients with a viral load of more than 10,000 copies/mL, who were seen at the center's general medicine practice.
Eighty-seven percent of the subjects were male, 53% had depression, 17% had a history of Pneumocystis carinii pneumonia and 12% had a history of injection drug use. More than half (63%) had AIDS and 54% had CD4 counts of less than 200 cells per microliter.
After adjusting for "secular trends in protease inhibitor use," Dr. Fairfield's group found that "factors significantly associated with delay of protease inhibitor initiation were higher CD4 cell count, higher viral load, history of Pneumocystis pneumonia, history of depression, and history of injection drug use."
To the researchers' knowledge, their report, published in the Journal of General Internal Medicine for July, is the first in which significant delays in protease inhibitor treatment were found to be associated with depression, drug use and higher CD4 cell counts. These delays in protease inhibitor initiation were unrelated with the physician's experience with HIV-infected patients or level of training in HIV care.
"Whether the observed delays for patients with depression or history of injection drug use are clinically appropriate remains unclear," they point out. However, because "clinical guidelines recommend therapy for patients with elevated viral load regardless of CD4 count," they believe that "educational initiatives may be needed to improve physician and patient acceptance of protease inhibitors when clinically appropriate."
"Concern about withholding medical therapy from people who are marginalized is appropriate," Drs. David R. Bangsberg of the San Francisco General Hospital and Andrew Moss of the University of California in San Francisco comment.
They also believe that "provider concern about patient nonadherence...may be a good reason for delaying HAART." For example, they say, there is some evidence for a relationship between patient depression and nonadherence to therapy for several diseases. The evidence of a relationship between injection drug use and poor adherence is more controversial.
However, the editorialists point out that "our ability to predict adherence in individual patients is dismal, perhaps not better than chance." Therefore, "given our imprecise understanding of adherence and its predictors, no person should die without a trial of therapy simply because the person was judged in advance to be nonadherent." (Reuters/Journal of General Internal Medicine)
HIV+ women have lower prenatal care rates
Although more HIV-infected women are receiving zidovudine (AZT) treatment during pregnancy to prevent vertical transmission of the virus, the number of HIV-infected women who receive prenatal care is still much lower compared with the general population, according to a report in the July 1st issue of the Journal of Acquired Immune Deficiency Syndromes.
Data on the effectiveness of zidovudine for the prevention of vertical transmission of HIV infection were first published in 1995. Dr. Amy Lansky of the Centers for Disease Control and Prevention in Atlanta, Georgia, and colleagues evaluated the changes in the rate of prophylactic zidovudine use, along with the rate of prenatal care, among HIV-infected women.
To this end, Dr. Lansky's group reviewed surveillance data on 221 HIV-infected women and their infants, collected in Dallas, Houston and San Antonio, Texas, between 1987 and 1996.
They found that "68% received inadequate or no prenatal care." Over the course of the study, the number of women who received adequate prenatal care doubled, increasing from 24% to 47%. The number of women treated with zidovudine tripled, increasing from 20% to 67%.
However, they also found that 10% of the women in this study received no prenatal care compared with 2% to 4% of pregnant women in the general population.
Dr. Lansky's group points out that "over and above the availability of effective therapies, adequate prenatal care can increase the likelihood that HIV-infected pregnant women who know their status are prescribed [zidovudine] in the prenatal period." The results therefore "underscore the urgent need to improve access to and use of prenatal care services."
Meanwhile, New York State begins a program on August 1st that requires all pregnant women who goes to the hospital for delivery receive an HIV counseling session - and which will force the newborn to be tested regardless of whether or not the mother has been.
She also will be urged to get an HIV test before her baby is born, if she was not tested during prenatal care. If she refuses the test, her baby will be tested as soon as it is born, and both mother and child must remain in the hospital until the results are confirmed.
Doctors don't quarrel with the state's intent -- to reduce the number of HIV-positive infants by encouraging every expectant mother to get HIV testing during pregnancy.
But the new policy will frighten parents unnecessarily and intrude on what should be a joyful family experience, doctors say. The rapid HIV test that will be used has a relatively high rate of false positives, they say.
The regulation also could interfere with breast-feeding, because a mother who tests positive will be encouraged to delay feeding until -- and unless -- she gets a negative test. That could take a week, said Dr. Frank Gigliotti, chief of pediatric infectious diseases at the Children's Hospital at Strong Medical Center in Rochester.
"I think they want to make hospital testing so unappealing the obstetricians will just test everybody beforehand," he said. "If that happens, it would be a good thing."
Newborns in New York state are already tested for HIV but are allowed to go home before the results are in, said Dr. Maggie Vill, a perinatologist at Rochester General Hospital. If the result is positive, the pediatrician calls the parents and the baby is retested.
The first HIV test on a newborn is not conclusive because it is done on cord blood, which contains antibodies from the mother, Vill said. Rapid HIV tests and cord blood tests have high rates of false positives, she said.
"A lot of people are saying, 'Why do this test that can be inaccurate?' " Vil. said. "You are scaring the mother, the father, everyone in the family."
And the stigma of HIV remains, she said. "Some people object to having the test done and the results in a hospital chart."
The state Health Department says the new policy is needed because only 53 percent of pregnant women in the state now get prenatal HIV testing. Using 1997-98 data, the state determined that, each year, up to 200 of those women may be HIV positive and unaware they have the infection.
HIV infection can be passed to the baby in the womb, during delivery or through breast milk. About 30 percent of HIV-infected babies experience a rapid decline, dying by age 5 or 6, Gigliotti said. The others have a slower disease process similar to AIDS in adults.
Early diagnosis is important because the drug AZT can prevent transmission to the infant.
Ideally, an HIV-positive woman takes the drug during pregnancy and receives it intravenously during labor, Gigliotti said. The baby is put on oral AZT for six weeks.
That regimen has cut the risk of infection to an HIV-exposed infant to under 10 percent, Gigliotti said.
But even if the mother has not been diagnosed and treated during pregnancy, the risk of transmission can be cut by two-thirds if she is given AZT during labor or if the newborn is given the drug soon after birth, the state says.
No adverse side effects have been seen in infants who are given AZT and later turn out to not have HIV infection, doctors say.
Dr. David Gandell, a Rochester obstetrician, says the motive for the law is admirable, but the means are "dangerous."
"If somebody is in labor, that is not the time to do a sexual history and tell them how they can reduce risk by using condoms," he said. "Now every woman will have to have HIV counseling and urged to get tests when she comes in for labor, even if she's 8 centimeters dilated."
Marilyn Menegus, chief of the microbiology lab at the University of Rochester Medical Center, said the rapid-result test that will be used has a false positive rate ranging from .5 percent to 3 percent.
Like others in health care, she questioned the need for the policy in Monroe County, saying almost all HIV-positive women here are diagnosed before they give birth. Last year, Menegus said, the county had about 10,000 births, and screenings found 20 mothers were HIV positive.
But 18 of the 20 were tested prenatally. "The other two babies were unknown to us. So the maximum benefit we can have from all this screening is two earlier diagnoses. To find those two, we will have to test an additional 5,000 women.
"I am really outraged about this because I think they are manipulating the public health law," Menegus added. The physicians' oath "first, do no harm" should apply to public health measures, she said. "There's the potential here to wreck what should be someone's happiest time." (Reuters/Journal of AIDS/Rochester Chronicle and Democrat))
Koop urges support of needle exchange
Washington, D.C. Police Chief Charles H. Ramsey and former surgeon general C. Everett Koop have written separate letters to House Speaker J. Dennis Hastert (R-Ill.) urging the House to not prohibit the District from spending money on a needle exchange program in the coming fiscal year.
"Having worked on the HIV/AIDS epidemic since its emergence in the U.S., I am now writing to express my strong belief that local programs of clean needle exchange can be an effective means of preventing the spread of the disease without increasing the use of illicit drugs," the Koop letter says.
Congress last year banned city spending on a needle exchange program it had funded for two years, forcing its closure. A private, nonprofit group has since started up to offer clean needles without any government funds, but Ramsey and Koop urged Congress not to reinstate the ban.
The House Appropriations Committee last week eliminated the ban from the District's fiscal 2000 budget bill, but the full House is considering a proposal adding it back.
MDs still need basic HIV management skills
A combination of the expertise of the specialist and the skills of the primary care physician is needed to provide optimum care for patients with HIV infection, according to a multicenter team of physicians.
Ten years ago, it appeared that HIV infection was becoming a "primary care disease," Dr. Frederick M. Hecht of the University of California in San Francisco and associates explain. However, "dramatic treatment advances have raised new concerns about how to optimize care for HIV-infected patients."
In the July 20th issue of the Annals of Internal Medicine, Dr. Hecht and members of the Society of General Internal Medicine AIDS Task Force report on their review of the most recent available data on HIV disease management.
Overall, evidence is accumulating that physicians who are experienced in caring for HIV-infected patients provide better overall care, they conclude, and that HIV management skill depends more on "...actual patient care experience and HIV expertise rather than on subspecialty training per se."
"Primary care physicians should not be expected to have sufficient expertise in HIV management to care for patients without the consultation of an expert," they point out. However, Dr. Hecht's team also identified three general areas in which primary care physicians do need to be competent.
First, they should be able to screen patients for HIV risk and to counsel them on risk reduction and testing. Second, they should be familiar with "...important symptom complexes that may indicate HIV infection or the development of HIV-related opportunistic infections." Finally, primary care physicians need "basic knowledge of HIV treatment options and prophylactic regimens for preventing opportunistic infections."
Dr. Hecht's group found "growing evidence that many primary care physicians have weaknesses in each of these areas of basic HIV skills." Specifically, it appears that many primary care physicians are not knowledgeable about current treatment recommendations for patients with newly diagnosed HIV infection.
In addition, many physicians fail to adequately screen patients for HIV infection and fail to recognize HIV-related conditions, resulting in delayed diagnosis.
Overall, the researchers conclude that the competence of primary care physicians in basic HIV skills must be strengthened "rather than relegating all attention to this disease to a limited number of AIDS experts." (Reuters/Annals of Internal Medicine)
Study finds pill coating kills HIV
An ingredient used to coat pills to help them last longer in the digestive system could offer a new avenue for preventing transmission of HIV, researchers have announced.
They said the ingredient kills not only HIV, but the herpes virus and the bacteria that cause a range of sexually transmitted diseases (STDs), including gonorrhea, trichomonas and chlamydia.
Formulated into a cream, it has worked in mice to prevent sexual transmission with no serious side-effects, said Dr. Robert Neurath, head of the Laboratory of Biochemical Virology at the New York Blood Center.
The ingredient is used to coat enteric tablets, which must dissolve in the small intestine rather than in the stomach. Known as cellulose acetate phthalate, it holds its own in the acidic environment of the stomach but breaks down in the more alkaline environment of the intestine.
It is classified as an "inert" substance -- one that has no active effects -- and Neurath said he never dreamed such a chemical would work.
"This was a step prompted by desperation," he said in a telephone interview.
Neurath's team had been looking for a microbicide -- something besides a condom that women, and men, could use that would protect them from STDs and especially HIV. Groups that lobby for the development of a microbicide say many men refuse to use condoms and beat sexual partners who demand their use.
The result is that many women are infected each year.
Advocates for microbicides argue that a cream that could be used easily and privately would save millions of lives.
About two years ago, Neurath said, his team modified a milk protein that worked well against HIV and herpes viruses.
But they ran into a roadblock -- mad cow disease. Bovine spongiform encephalopathy (BSE) had swept British herds and there were some suggestions it could be passed on in milk.
"There was some concern expressed that milk-derived products should not be used for medicinal purposes," Neurath said. So his team had to look for something else.
"We decided to either have a quick success or get out of the field of microbicides," he said.
"We looked for something inexpensive, widely available, with possible broad activity. We also suspected that other people probably never actually screened what are called inactive ingredients for activity, so we thought we would be the only ones doing it."
They trawled through several hundred compounds listed in a book, testing each one against HIV.
Finally they came upon cellulose acetate phthalate. Writing in the British journal Biologicals, published by the International Association of Biological Standardization, they said they formulated a cream containing the compound.
Not only did it work in mice to kill viruses and bacteria, but it did not kill the "good" bacteria such as lactobacilli, which belong in a healthy vagina.
Neurath's team did not test it against sperm but assume that it will inactivate sperm, acting as a contraceptive.
Other researchers are racing to get microbicides to market and have found them in similarly unlikely places, such as a detergent widely used in toothpaste.
"We were trying to avoid the use of detergents because detergents affect cells," Neurath said.
Because cellulose acetate phthalate is widely used in tablets, it must be safe, he added.
He feels the discovery was simply lucky.
"There were other compounds used for tablet coating which are similar to the one we discovered which had absolutely no activity," he said. "I think it was a chance discovery."
The United States has the highest incidence of STDs in the industrialized world, with 66 million people, or more than one in three people aged 15 to 65 infected with at least one incurable STD such as HIV or herpes.
An estimated 42 million people worldwide are infected with HIV and 13 million have died of AIDS, according to the World Health Organization. AIDS is now the fourth leading cause of death worldwide.
Neurath's team is working with the National Cancer Institute and other groups to develop the cream.
Names reporting called deterrent to testing
Name-based reporting of HIV -- the HIV reporting method expected to be instituted by Gov. Ridge in Pennsylvania later this year -- may undermine efforts toward HIV surveillance and testing if no attempt is made to change attitudes about the procedure, according to new research.
Researchers from the University of California, San Francisco, gave 130 high-risk, male, repeat testers information on the benefits of name-based reporting of HIV and asked them their intentions with regards to being tested. Sixty-three percent of the 67 men who were randomly selected and questioned about their intentions prior to hearing the benefits responded that they would not be tested if reporting were mandatory. Nearly 20 percent changed their minds after learning the benefits of name-based testing.
The report showed that 44 percent of the men who were asked only after hearing the benefits responded that they would not test.
Jackson won't drop African drug fight
U.S. Rep. Jesse Jackson, Jr., (D-Chicago), is continuing his efforts on behalf of access to low-cost AIDS medication for sub-Saharan Africa, where the disease is sweeping through the region.
Jackson plans on introducing legislation, originally contained in a broader African development bill the House refused to consider, to prevent the U.S. government from applying sanctions against African nations that allow the manufacture of low-cost generic substitutes for American-made AIDS drugs.
In the name of protecting the intellectual property and research investment of U.S. drug-makers, American trade officials have been waging a campaign against the manufacture of the knockoff drugs.
The cost of a week's dosage of AIDS medication is more than what the average worker in sub-Saharan Africa earns in a year. So the South African parliament passed legislation in 1997 allowing its pharmaceutical companies to ignore overseas patents on AIDS drugs and make generic substitutes available for sale inside the country.
The threat of sanctions so far has kept the low-cost substitutes off the market.
But the plight of the HIV-infected poor in Africa has become a growing cause among AIDS activists, including demonstrators from ACT-UP who repeatedly disrupted the recent campaign announcement tour of Vice President Al Gore.
Meanwhile, a US trade official has reiterated that the United States was committed to helping South Africa obtain cheaper AIDS drugs as long as it "obeyed international trade rules."
Assistant US Trade Representative Joseph Papovich told a congressional panel that the United States would support South Africa's use of two controversial trade measures as long as it did not threaten the patent rights of drug makers. He was unclear as to how that could be accomplished.
"Our goal is to chart a course that will assist in improving access to affordable medicines while not threatening the financial incentives that fuel continued research," Papovich said.
The House subcommittee hearing turned the spotlight on a trade issue that has outraged advocates for AIDS patients and consumer groups and has haunted Gore's presidential campaign. Vocal protesters from ACT-UP have criticized Gore for taking the lead in the administration's efforts, which have landed South Africa on the government's trade "watch list" until the matter is resolved.
Gore said that he is working to resolve the dispute, which centers on a South African law that could let local manufacturers make cheap, generic copies of AIDS drugs, a practice known as compulsory licensing, or import drugs from a third party through so-called parallel imports. The US pharmaceutical industry opposes compulsory licensing and says that just supplying drugs will not necessarily help people in African countries that often lack physicians and hospitals needed to make sure patients take their medicines.
A 37-year-old HIV-positive mother from the African nation of Malawi pleaded with lawmakers to help make drugs available. Chatinkha Nkhoma, who now lives in the United States, said that she would die if she returned to her native country, where 20% of the population is infected with HIV and drug treatment is almost nonexistent.
"We need these drugs in order to survive this catastrophe," Nkhoma said. "We cannot be condemned to death because we are poor."
Testifying for the Pharmaceutical Research and Manufacturers of America, Dr. John Siegfried said, "Many countries lack the broad public health infrastructure necessary to support the use of complex regimens of anti-HIV treatments." Sandra Thurman, director of the Office of National AIDS Policy, countered that "a successful fight against AIDS is fundamentally important to our ability to sustain and improve our economic ties to Africa." The administration's $100 million grant to Africa, she said, "more than doubles our funding for programs of prevention and care in Africa, and challenges our G8 and other partners to similarly increase their efforts."
Also at the hearing, while taking care to praise the administration's recent efforts, several witnesses - and some subcommittee members -- decried the administration's attempts to appease the pharmaceutical industry over the lives of South Africans.
Subcommittee member Rep. Henry Waxman(D-CA) said, "I regret that this hearing only focuses on U.S. trade policies towards South Africa. ... I dearly hope that ... this administration and this Congress dedicate the same vigor and energy to ending the HIV/AIDS epidemic as to defending the rights of the prescription drug industry."
Peter Lurie, of the Public Citizen's Health Research Group, said, "The explanation for the pharmaceutical companies' opposition [to compulsory licensing] is to be found ... in their desire to not have their irrational pricing practices exposed." Dr. Allen Herman, dean of the National School of Public Health of Southern Africa, said, "We cannot simply import treatment regimens from other countries ... It is my hope that you will agree that ... the cost of drugs, whilst important, is a small part of the battle against the HIV/AIDS epidemic in Southern Africa." And ACT UP's Eric Sawyer added, "The first priority for extending the lives of people living with HIV/AIDS in the developing world should be providing access to very inexpensive drugs that treat and prevent the development of opportunistic infections that kill most people with AIDS." Sawyer called upon Congress to hold hearings on the "real cost of drug development" and the drug pricing practices of pharmaceutical companies and to pass legislation that would bar the U.S. from "bullying" developing countries into "denying its people affordable access to essential medicines through legal trade practices such as compulsory licensing."
Jackson said that Congress should enact legislation that clearly spells out US support for compulsory licenses and parallel imports as a way to help fight the AIDS crisis in developing countries. "If Congress is serious about addressing these problems, we have the power to do this," the Illinois Democrat said. "We can either be politically correct and side with pharmaceutical companies or be morally correct and side with millions of afflicted people...in sub-Saharan Africa." (Chicago Tribune/Associated Press/Reuters)