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Issue #223: April 2, 1999
fastfax is available by fax in the 215 and 610 area codes at no cost, or by mail anywhere for $20.00 per year, by calling 215-545-6868, and by E-mail by contacting and type the message SUBSCRIBE in the message section. Sources for some articles in this issue include AIDS, American Journal of Public Health, Associated Press, Baltimore Sun, Canadian Press, Johns Hopkins School of Public Health, Reuters.
In This Issue:
Abbott asks FDA to approve new Norvir gel capsule
Balt. needle program doesn't increase crime: study
Activist challenges hypericin study
Finding may improve drug action on brain
Governors want AIDS funds in block grant
Shared sewing needles start HIV scare
Canadian dentists resist AIDS care
AIDS Library celebrates National Poetry Month
Abbott asks FDA to approve new Norvir gel capsule
Drug maker Abbott Laboratories Inc. has filed for U.S. Food and Drug Administration approval for a new capsule form of its Norvir anti-AIDS drug, which had been in short supply because of production problems last year.
Abbott said it was seeking U.S. approval for a soft-gel capsule and had already filed for approval in Europe. The company said it had been working to develop a new capsule form after production problems forced some of the roughly 60,000 HIV-infected patients who had been taking Norvir capsules to switch to the liquid form.
Last September, Abbott said it was running out of Norvir capsules because of problems involving the formation of an undesired crystalline structure that changes how the capsules dissolve.
"The reintroduction of Norvir capsules has been a top priority for Abbott Laboratories," John Leonard, vice president of pharmaceutical development at Abbott, said in a statement. "Abbott appreciates the cooperation it has received from patients, health care providers and regulatory authorities as Abbott employees worked to resolve the problem."
Abbott said it could not predict when the new capsule might be approved. It said the Norvir liquid would continue to be available to all users in the meantime. Norvir is one of four major protease inhibitors taken to fight HIV, and is usually combined with other drugs, such as AZT.
Norvir ranks fourth in the estimated $2.2 billion world protease inhibitor market. The drug has a loyal following among some doctors and patients in the United States and Europe, but Zisson said Abbott probably lost some patients to other drugs when it stopped making the capsule form last year. Liquids are harder to carry and often must be mixed with juice or another liquid.
Zisson said Abbott was testing a second generation of Norvir, which he said could someday become the "best protease inhibitor on the market."
Balt. needle program doesn't increase crime: study
by Jonathan Bor
Baltimore Sun
Distributing clean needles to addicts has not contributed to drug-related crime or to the number of discarded syringes in streets and alleys, according to a study of Baltimore's needle-exchange program.
Researchers at the Johns Hopkins School of Public Health said arrest patterns were not significantly different in areas served by the program than in other areas of the city. This held true for cocaine and heroin possession as well as burglaries, prostitution and other crimes linked to drug activity.
By making clean needles available, the city's Health Department hopes to stem the AIDS epidemic by reducing the practice of sharing dirty, virus-laden syringes. Dr. Peter Beilenson, the city's health commissioner, said the study should answer concerns that the program might contribute to the drug problem by sending an unintended message that drug use is acceptable.
"It's not the science that's in question, it's the politics," said Beilenson.
This year, Baltimore's program runs on a budget of $321,000, which pays for staff, vans and needles. Another $250,000 pays for treatment slots for needle-exchanging addicts who say they want to quit.
A U.S. Senate bill would permanently ban the use of federal money for such programs. While the city relies on state and city money, Beilenson said federal funding would allow for an expansion of the program, one of the largest in the country.
About 8,300 addicts are registered in the program, which has dispensed 2.3 million needles during the past 4 ½ years. Addicts receive a clean needle for every dirty one they return. Two vans visit eight sites around the city on a rotating basis -- returning four times a week to some sites, twice to others. In the study, researchers examined arrest trends in the eight-month period before the program began and in the two years that followed.
The study found that cocaine and heroin arrests rose in neighborhoods that lie within a half-mile radius of the distribution sites, but not significantly more than in the rest of the city. Burglaries and prostitution declined in the areas near the vans, but not by a significantly wider margin than elsewhere. In a separate study, 500 high school students were asked in a questionnaire what factors would most likely prompt them to use drugs. Almost half said they might use drugs if a friend or family member started to do so. In contrast, 11 percent said that seeing someone at a needle-exchange program would have that effect.
"It was quite clear that the major factors contributing to kids using drugs were friends, peers and parents," said Dr. Steffanie Strathdee, one of the Hopkins scientists.
A previous study found that drug use did not increase among addicts taking part in needle exchange, said Dr. David Vlahov, a Hopkins epidemiologist who studies the link between drug addiction and acquired immune deficiency syndrome.
Dr. Herbert D. Kleber, former deputy U.S. drug czar who heads Columbia University's Center for Addiction and Substance Abuse, said such studies do not answer his philosophical concerns.
"I think it's a temporary solution to a more serious problem," said Kleber. "I think good treatment is much more likely to decrease risky behavior than needle exchange programs. All they do is perpetuate dangerous behavior." © Baltimore Sun
Vancouver study "clarified"
An earlier study, conducted in Vancouver, had indicated that HIV infection was more, rather than less, common among people who used needle exchange programs. But a new study seeks to "clarify" those results, indicating that the increased level of HIV infection is due to other high-risk behavior on the part of program participants.
Dr. Martin Schechter of the University of British Columbia, who conducted the earlier study, says in the March issue of the journal AIDS that interviews with 700 injection drug users showed that "People who go to needle exchanges are at much higher risk. Therefore it's to be expected that their rate (of HIV) would be higher." He said he was concerned that the earlier study results, which indicated that the HIV infection rate among needle exchange users was almost twice that of those who infrequently used exchange sites, has been used by opponents of syringe exchange to eliminate such programs.
He said that he believed the major hindrance to effective needle exchange programs is that they are not supported by properly funded housing, detox beds and other services."
Schechter told the Canadian Press, "People were quoting our study in Congress, using it to suggest that the needle exchange in Vancouver made things worse. I felt that my data had been misinterpreted. I felt disappointed and a bit outraged our data were being used for ideological reasons. My hope would be that people who misinterpreted the data in the past would have an opportunity to look at the present data."
Activist challenges hypericin study
In last week's fastfax, it was reported that a study had indicated that Hypericin, one identified active ingredient in St. John's wort, may trigger severe skin reactions in AIDS patients. The report noted that the study contrasted with previous reports that found that hypericin might have an anti-HIV effect But a prominent treatment activist has raised concerns on the study.
George M. Carter, Director of Treatment Information Development for Direct Access Alternative Information Services( which was formerly DAAIR, Direct AIDS Alternative Information Services), called the study and its conclusions "very misleading."
"Most people I know with HIV who use the whole herb are not trying to get an antiviral bang from it, but mostly to treat depression. There is one report in the case literature of a woman who took excessive doses of St. John's wort herb and then went sunbathing."
Carter also noted that the study's results are not new, and that the toxicity problem had already been identified as related to a high dose, synthetic hypericin extract.
Carter called the report "alarmist" in that it ignored the primary reasons people with HIV are taking the drug and confused the synthetic extract with the herb. He noted that studies are underway to see if lower doses of hypericin may affect hepatitis C virus without the phototoxicity.
Dr. Roy Gulick, of the Cornell Clinical Trials Unit in New York City, published the results of his study in the March 16th issue of the Annals of Internal Medicine.
According to Gulick's team, laboratory trials in mice have suggested that hypericin might "interfere with steps in the replicative cycle" of HIV - inhibiting proliferation of the virus. He said that many HIV-positive individuals currently use St. John's wort in the belief that it can help fight the virus.
Gulick's team notes that St. John's wort and other "preparations containing hypericin are largely unregulated and contain varying amounts of (the) drug." They advise that individuals consuming these types of products be made aware of the danger of side effects. Carter agrees that it may be prudent to avoid excessive sunbathing if using St. John's wort, but views the term "danger" as somewhat excessive. Still, Carter agrees that a more stringent set of regulations to govern dietary supplement quality is needed but the Food and Drug Administration has failed to do so.
Gulick speculated that other compounds related to the whole herb "may have antiretroviral activity and could be investigated" in future trials. Carter points to the possibility of a mix of herbs that alone have some impact on the virus but may work better in combination. Several members of DAAIR are trying such an herbal combination therapy.
Finding may improve drug action on brain
Researchers have announced that they have found a second barrier that keeps most drugs from reaching the brain, a discovery that could help scientists make drugs more effective.
Both of the barriers are patrolled by proteins that act like chemical bouncers or doormen, and it might be necessary to disable both of them to get drugs into the brain, they said.
"Our finding provides a molecular mechanism for explaining one part of the blood-brain barrier," Dr. David Piwnica-Worms, a professor of radiology at Washington University School of Medicine in St. Louis, said in a telephone interview with Reuters Health Information Service.
"It provides an opportunity to block these when it is desired to get things into the brain."
For instance, taking the two proteins out of action might help get powerful HIV drugs such as protease inhibitors into the brain, where HIV is believed to evade drugs, Piwnica-Worms said.
Scientists have long known that a guardian protein called p-glycoprotein (Pgp) works in the tiniest capillaries leading into the brain to protect delicate brain cells that are hard for the body to replace.
"Most things that we eat or ingest or are floating around through the blood do not get through these cellular channels," Piwnica-Worms said. But Pgp also stops most drugs from getting into the brain. "It recognizes dozens and dozens of drugs, including protease inhibitors and psychoactive drugs," he said.
Working with rats, mice and with a few human volunteers, Piwnica-Worms's team found there is a related protein called multi-drug resistance protein (MRP) that also acts to block drugs.
"They act like bouncers. They either pump things out or they don't let things in," said Piwnica-Worms, whose findings were reported in the Proceedings of the National Academy of Sciences.
MRP is not new to doctors -- it is used by cancer cells to pump out drugs used to fight cancer. But this is the first time it has been found to protect the brain.
Drug companies have been working on ways to inactivate Pgp and get their drugs into the brain. They will probably have to tackle MRP as well, Piwnica-Worms said.
"Four out of five molecules are recognized by both," he said. "If you just eliminate Pgp, you could get (a drug) in but the other one would pump it back out. So you really have to do both."
But scientists ought to be able to find a way to do that, eventually. "Once you know the bouncer's there, you can add drugs to block the bouncer," he said.
Governors want AIDS funds in block grant
The National Governors Association (NGA) has called on the federal government to divide its Title I Ryan White CARE Act funding among the 50 states, rather than making direct grants to individual cities and regions.
If the Clinton Administration agrees to the proposal, all Ryan White Care Act funding which currently is directly awarded to the Philadelphia region - over $16 million this year - would be given instead to the state health department in Harrisburg.
The federal government already "block grants" funds for welfare, mental health and substance abuse services to the states, as well as other health and human services programs. Funds for AIDS Drug Assistance Programs and funding available under Title II of the Ryan White Act are already distributed to states according to a block grant formula.
While unlikely to be accepted this year, the governors' proposal is apt to be more popular with a Republican president, should one be elected in the 2000 elections. Republicans have generally been more favorable to block grants, since most major cities have Democratic mayors while most state houses are under Republican control.
In Pennsylvania, the proposal would mean that the Ridge Administration would be in the position of determining how much Title I funding was made available to the Philadelphia area, and what services it could be spent on. The state could choose either to continue to use the Title I planning council - the Philadelphia EMA HIV Commission - to set priorities for the funds, use the Title II council - The Philadelphia AIDS Consortium - or set up a new mechanism for prioritizing and distributing the funds.
State block grants would also eliminate the complicated planning process that grows out of the Title I formula of distributing funds by metropolitan region. Philadelphia's metropolitan region stretches over nine counties in two states, Pennsylvania and New Jersey, and there has historically been great tension between the Pennsylvania and New Jersey counties, as well as between urban centers like Philadelphia and Camden and more rural suburban counties.
Because the incidence of AIDS in the New Jersey counties is also lower than in the Pennsylvania sector of the region, a state block grant approach might actually increase Title I funding for the Philadelphia area, since current Title I funding levels are to some extent "watered down" because the current Title I formula, based on population as well as AIDS cases, includes less populated and less AIDS-affected counties as part of the Philadelphia area calculation.
Most local AIDS advocates as well as local health departments in the five-county Philadelphia metropolitan region have been severely critical of AIDS policy in Harrisburg, especially with regard to coordination between the Title I and II planning councils and the Ridge Administration's HealthChoices Medicaid managed care program, which most believe has put new obstacles in the way of access to quality primary care for people with HIV disease.
Joe Cronauer, co-director of the Philadelphia AIDS Activities Coordinating Office, told the HIV Commission earlier this month that the NGA proposal could have a serious negative impact on local AIDS service delivery, since the Philadelphia area has never fared particularly well in competing for AIDS dollars on the state level. While the overwhelming majority of AIDS cases in the state occur in the Philadelphia area, the state has never distributed its own AIDS funds, or the Title II money it receives, to Philadelphia in the proportion which could be expected with the concentration of AIDS cases here.
The state has also refused to spend any of the AIDS prevention dollars it receives from the U.S. Centers for Disease Control and Prevention in Philadelphia, claiming that since Philadelphia is directly funded by the CDC for AIDS education services it should concentrate state CDC funds in the state's other 66 counties. A direct state allocation of about $800,000 for AIDS services to Philadelphia has remained unchanged since 1988.
Two NGA policy papers adopted at the winter meeting of the group earlier this year strongly encourage the federal government to use block grants for AIDS and other services.
"The Governors call on the federal government to work in partnership with states and the private sector to reduce the costs of treatment and to maintain funding that adequately reflects the growing cost of [AIDS] drug therapies," one statement reads. "Funds provided through the [Ryan White] act should be awarded through states to ensure the coordination of efforts at the state and local levels."
"Block grants can provide a simpler, more rational, and more flexible delivery system for federal aid. Administrative savings from consolidation at the federal and state level will be used by states to enhance services," another statement said.
The "better coordination" of AIDS services, a goal of the NGA statement, is one that is shared locally by most people living with HIV/AIDS and AIDS service organizations. Many have complained at the lack of joint planning between the HIV Commission, with its $16 million in Title I funds, and the Philadelphia AIDS Consortium, with approximately $3.5 in Title II funds, and that the cost of administering federal AIDS funding is higher because the two programs have to pay separately for planning, contract monitoring, and other services.
TPAC has come under the most severe criticism for its planning and allocation processes, which are generally less publicized and gain less participation from people with HIV/AIDS than do the HIV Commission's processes.
Title I, II disputes increase
Disputes between the Commission, AACO and TPAC have also become more common. AACO and TPAC routinely blame each other for the lack of coordination in the planning and priority-setting processes. A recent AACO decision to withdraw almost $115,000 in Title I funds from TPAC's diagnostic and evaluation project (which provides initial medical diagnosis and treatment to uninsured people with HIV) because of what AACO claimed was high administrative cost was challenged by TPAC's Larry Hochendoner, who charged that AACO was mis-stating the program's administrative costs.
AACO claims that TPAC was spending almost 36% of its Title I allocation on staff and administrative overhead, while TPAC says that only 9.6% of the funds were actually used for administration.
In any case, AACO re-allocated its diagnostic funding to Philadelphia FIGHT "at minimal administrative expense," and TPAC continued with its own program using $155,000 in Title II funds. As a result, two different diagnostic and evaluation programs must be navigated by PWAs and providers.
AACO also increased its basic Title I allocations for each of the Title I primary care providers by an amount equal to their income from the diagnostic fund last year, which it said was more efficient because it eliminated the "middle man" role formerly played by TPAC in distributing the funds.
AACO also claims that TPAC is "denying access to Title II Diagnostic and Evaluation Funds" to Title I primary care providers," and says it has asked TPAC to "rectify the situation."
Shared sewing needles start HIV scare
Twenty sixth-graders who shared sewing needles to draw blood for a classroom science experiment are being urged to be tested for HIV and hepatitis.
The teacher in charge of the experiment, conducted at the Bierbaum School in Mehlville, Missouri, has been placed on administrative leave pending an investigation, said Michele Ludwig, spokeswoman for the Mehlville School District. She would not identify the teacher but said he had worked in the district for four years.
Students used one of two sewing needles to prick their fingers and draw blood, which was placed on a slide and viewed under a microscope. The teacher immersed the needles in alcohol and swabbed them after each use, so district and health officials believe it's unlikely that a student could contract hepatitis or HIV.
"We just want to put the parents at ease, and that's why we're recommending they go for the testing," Ludwig said.
Ludwig said the experiment was unauthorized.
"We do not share needles, and the district does not condone doing experiments with blood," she said.
Parents also apparently were not told about the experiment beforehand.
The experiment was done in two classes. Although about 50 students are in the classes, only 20 volunteered to prick their fingers, Ludwig said.
The district learned what had happened after a student in one of the classes learned in health class not to share needles. The student told his or her parents, who contacted the school, Ludwig said.
Letters were sent to parents of the 20 children who took part in the experiment. The letter asks parents to have their children tested for hepatitis B and C, which cause liver disease, as well as the AIDS virus. The district will pay for the testing costs.
Standard medical procedure calls for using a fresh needle for each person, said Lynn Feltmann, communicable disease specialist for the St. Louis County Department of Health.
The risk of spreading HIV or hepatitis is much higher with a hollow-core needle that draws blood, Feltmann said.
"If there's a plus about this at all, it's that it was a sewing needle and not a hypodermic needle," said Steven Fine, director of the public health division.
The Multicenter AIDS Cohort (MACS) study that has followed a group of 5,622 homosexual and bisexual men nationwide to determine if, when, and why they contract HIV reached its fifteen-year milestone on March 31, 1999.
Among the achievements of the MACS study was the development of physician guidelines for when to initiate anti-retroviral therapy. The guidelines were adopted by the United States Public Health Service and have become the standard for doctors to use when making the decision to start this life prolonging treatment. The study produced data that showed when those infected with HIV might expect to develop AIDS based on their viral load and CD4 counts, and has tracked the evolution of the HIV virus over the course of the disease for the past fifteen years.
The MACS began in 1983 when B. Frank Polk, MD, MS of the Johns Hopkins School of Public Health predicted a major epidemic stemming from reports of small, but growing clusters of pneumonia and Kaposi's sarcoma among homosexual men. Dr. Polk recruited study members from the gay communities in Baltimore and Washington as a way to help them fight the disease which came to be known as AIDS. Joseph Margolick, MD, PhD, head of the MACS center in Baltimore said, "There were only a few people in the world who knew there was going to be a major epidemic. Frank Polk had the confidence in his own vision to go out on a limb and start this study." MACS grew to include four sites around the country and more than 5,000 participants. Because the study members were largely highly educated and highly motivated, they took an active part in giving feedback and working with the researchers. "The amount of participation takes my breath away," said Dr. Margolick.
Over the years the MACS has produced a body of data on how HIV enters the body, what it does as time progresses, and what determines the occurrence of AIDS. MACS participants are evaluated every six months. Each visit includes a questionnaire about all aspects of their health status, a physical examination, and taking of blood samples. All the data from every visit throughout the country is processed through the Center for the Analysis and Management of the data from MACS, under the direction of Alvaro Munoz, PhD, at the Johns Hopkins School of Public Health. The MACS has generated information from 82,382 person visits, and has logged information from 68,255 CD4 measurements while tracking 5,084 variables that contribute to the development of AIDS.
More than 600 research articles have been published based on the MACS, ranging from the role of CD4 lymphocyte counts and viral load in predicting AIDS, to average incubation time, to the genetics of AIDS -- why some people handle the virus so much better than others. Over the years, the MACS has provided critical data about early events in the course of HIV infection and about conversion to AIDS. The study also looked at factors that might be involved in transmitting the infection and helped identify the most important ones. Finally, the MACS has built a repository of biologic specimens, which along with detailed epidemiologic data, has been used in a wide variety of studies by AIDS researchers nationwide.
The MACS sites are the Johns Hopkins School of Public Health in Baltimore, Maryland; Northwestern University Medical School Howard Brown Clinic in Chicago, Illinois; the University of California Schools of Public Health and Medicine in Los Angeles; and the University of Pittsburgh Graduate School of Public Health in Pittsburgh, Pennsylvania. The MACS is funded by the National Institute of Allergy and Infectious Disease of the National Institutes of Health and supplemented by the National Cancer Institute.
Data from the MACS can be accessed at http://www.statepi.jhsph.edu.
Canadian dentists resist AIDS care
Despite the fact that dental associations have stated that dentists have an obligation to provide care to patients with infectious diseases, about one in six Canadian dentists report that they refuse to treat HIV-infected patients.
The finding of a survey sent to 6,444 Canadian dentists are reported in the April issue of the American Journal of Public Health. Dr. Gillian M. McCarthy of the School of Dentistry at the University of Western Ontario in London and colleagues evaluated data from 4,107 respondents.
Most of the respondents were general practice dentists (89%) and most were men (81%). Overall, Dr. McCarthy's group found that about "16% of respondents claimed that they would refuse to treat any patient with HIV." The researchers also "estimated that the percentage of respondents who reported refusal to treat patients with HIV would have been 1% higher with a 100% response rate."
Of the dentists who would refuse to treat HIV-infected patients, 37% said they were also unwilling to treat patients with hepatitis B virus, and 35% reported that they would not treat injection drug users.
"The strongest predictor of refusal to treat was lack of ethical responsibility," Dr. McCarthy's group reports. The investigators also identified other significant predictors of refusal to treat HIV-infected patients, which included fear of losing patients, staff fears, cost of infection control procedures and safety concerns.
Based on these results, Dr. McCarthy' group concludes that a greater emphasis on teaching biomedical ethics is needed in undergraduate, postgraduate and continuing dental education. Education on the infectivity of blood-borne pathogens and infection control as a part of dental training should also be improved.
AIDS Library celebrates National Poetry Month
The AIDS Library will be celebrating National Poetry Month in April by hosting their thirdf poetry reading by local poets.
This year the featured poets will be River Huston and Cy K. Jones.
River Huston was the 1995 Poet Laureate of Bucks County, outside Philadelphia. She is the author of two books of poetry, Jesus Never Lived Here and The Bones of Susan. She writes a regular column for POZ, a magazine concerned with people living with HIV.
Cy Jones is the author of Sweep, his first book of poetry. He has been anthologized in Live at Karla's, a collection of work from various artists in the New Hope Slam scene, and A Different Latitude, a collection published by the Delaware Valley Poets. Mr. Jones represented New Hope and Philadelphia in 1994 at the National Poetry Slam Festival in North Carolina in 1994. He works as an HIV and addictions counselor.
Jenny Pierce, director of the AIDS Library, said that when the library "started doing poetry readings...we had no idea how they would touch the larger community. They have been our most popular presentations. Once again we join with the Academy of American Poets to celebrate National Poetry Month."
The poetry reading will be held on Thursday, April 29th beginning at 6 p.m. at the Library, 1211 Chestnut Street, on the 7th Floor. Light refreshments will be served, and there is no cost for the event.
Meanwhile, the Library has also announced an "Amnesty Month," as part of its National Library Week events. People who have failed to return books and videos can return them without paying late fines or risking their library privileges during the month of April any weekday from 9 a.m. to 5 p.m.
The Library's regular hours are Tuesday, Thursday and Saturday from noon to 5 p.m., Wednesday from 2 to 7 p.m., and Friday from 10 to 5 p.m. The Library is closed Sunday and Monday. Overdue books and videos can be returned on any weekday, however.
WTP plans bowling party April 25th
We The People will sponsor a bowling party for people with HIV/AIDS, their friends and families on Sunday, April 25th, from 1:00 to 6:00 p.m. at St. Monica's Lanes, located at 16th and Shunk Streets in South Philadelphia.
Tickets are available at We The People's Life Center at 425 South Broad Street or by phone at 215-545-6868. A raffle drawing offering cash prizes up to $150 and other gifts will also be held, with tickets for the drawing available at $1.00 each.
For more information, call 215-545-6868 or email to .
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