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Issue #175: May 3, 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 AIDS Treatment News, Chicago Tribune, Morbidity and Mortality Weekly Report, Philadelphia Inquirer, Reuters.Major city gene study debunked
Viagra may pose risk to some PWAs
House bars needle exchange funding
Illinois approves HIV name reporting
HIV still on rise, CDC confirms
May Wellness schedule announced
Major city gene study debunked
A Philadelphia scientist's 1994 study that claimed that the insertion of a gene into HIV cells would disable the cell's ability to do harm was a result of "extraordinarily careless science" and is not worth pursuing, according to an investigation by Philadelphia's Thomas Jefferson University.The study was highly-publicized four years ago as one of the most promising gene therapy approaches to treating HIV disease. Lingxun Duan, a researcher at Jefferson's Center for Human Virology, took a leave of absence during the university's months-long investigation, has since decided not to seek renewal of his contract, according to a report in the Philadelphia Inquirer.
Duan's claim in various medical publications in 1994 was that by inserting a synthetic gene into an HIV cell, the gene would act as an antibody to the "Rev" protein in the cell, which HIV needs in order to replicate. By binding to the Rev protein, the gene would make it impossible for HIV cell to replicate, Duan's study showed.
Duan's approach, which he said he could prove in lab experiments, was headed for federally-approved human testing when charges that his research was flawed led to the Jefferson investigation.
Other scientists have been unable to duplicate Duan's results in lab experiments.
Jefferson's concern about the validity of the research began with a complaint from Yong Wu, a Jefferson virologist, that the gene constructed by Duan was missing an essential component of the genetic DNA sequence. Wu stated that the published sequence of Duan's gene was inaccurate, and that even correcting for the error, the gene was missing the essential element that it needed to be able to bind to the Rev protein.
Wu testified in the investigation that Duan asked him to keep his concerns secret, and threatened him with reprisals in his homeland of China if he pursued the matter. Wu said he had to change his address and "make myself very scarce" after the threats.
Duan denied these charges, although the Jefferson investigation concluded that Duan "probably did" threaten Wu with retaliation by Chinese authorities. The committee found no evidence that Duan was capable of actually following up on the threat, however.
Another Jefferson researcher, Omar Bagasra, has charged that Duan purposely fabricated his experiments to make them appear successful, and that if the approach had ever been tested in humans, it would have been "toxic," according to the Inquirer.
The Jefferson investigation concluded that while the research was faulty, "the total evidence does not sufficiently support a finding of willful fabrication of data and scientific misconduct," although it admitted that the research had "significant problems." The committee also recommended Duan's dismissal and ordered him to send notices to various medical journals to correct the 1994 reports.
The federal Office of Research Integrity is now reviewing the results of the Jefferson investigation. Roger J. Pomerantz, the head of virology research at Jefferson, said that his center will continue to test other genetic approaches to inhibiting HIV replication.
Viagra may pose risk to some PWAs
by John S. JamesAIDS Treatment News
Using poppers (nitrate inhalants) at the same time as the new impotence drug Viagra (sildenafil) can cause dangerous hypotension (abnormally low blood pressure) because of the way the two drugs interact. Viagra's developer, Pfizer Inc., did not run interaction tests with the street drugs, but it did test combining Viagra with nitrates used for treating angina (a heart condition), which work similarly.
Due to the results of these tests, the package insert contains the following warning: "Viagra was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors or nitrates in any form is therefore contraindicated."
Viagra does not affect the blood levels of protease inhibitors, or other drugs used in HIV treatment, as far as is known. However, protease inhibitors (especially ritonavir) and certain other drugs (for example, ketoconazole, itraconazole, or erythromycin) increase the blood levels of Viagra by inhibiting the enzyme p450 3A4, which the body uses to eliminate Viagra. Pfizer does not expect this effect to cause serious risks, but does suggest that patients using such drugs consider trying a lower dose of Viagra first. Pfizer has not tested its drug with ritonavir or other HIV protease inhibitors, however.
Viagra is usually taken as a 50 mg dose, from half an hour to four hours before sexual activity, preferably one hour before. This dose can be decreased to 25 mg., or increased to 100 mg., depending on efficacy or side effects. Overdoses up to 800 mg have been tested, and have caused increased side effects including headache, facial flushing, and visual abnormalities, but did not present serious safety concerns; these higher doses had no significant increase in efficacy. For patients using p450 3A4 inhibitors, or who have other conditions which can interfere with the elimination of Viagra, the package insert suggests trying a lower dose: "Since higher plasma levels may increase both the efficacy and incidence of adverse events, a starting dose of 25 mg should be considered in these patients."
For more information, contact AIDS Treatment News at 415-255-0588 or 800-TREAT-1-2; fax 415-255-4659; or email to .
House bars needle exchange funding
The U.S. House of Representatives has overwhelmingly approved legislation that would permanently ban federal funding for needle exchange programs designed to prevent the spread of HIV.The bill was approved by a vote of 287-140, over the objections of a majority of House Democrats as well as the Clinton administration, which last week bypassed an opportunity to lift the funding ban that has been in place. At that time, the administration issued a report showing that studies have demonstrated that needle exchange programs can reduce the spread of HIV while not encouraging drug use.
The administration issued a statement calling for the measure's defeat, noting that "...the top public health leadership of the federal government remains the appropriate place for this [funding] determination, and the decision on which HIV-prevention strategies to use should rest with state and local officials."
Also opposing the bill was the American Public Health Association. "Congress should be taking action now to release federal funding for needle exchange programs rather than enacting a ban on such support," wrote APHA Executive Director Dr. Mohammad Akhter in a letter to members of the House.
Backers of the bill, however, argued that the science is far from clear on the subject. "Needle exchange programs do not save lives; they destroy hope and opportunity, ruin families and communities, and in some cases are destroying nations," said Rep. Jerry Solomon, R-NY, the bill's sponsor. "The Clinton Administration's endorsement of needle exchange programs is part of an intolerable message to our nation's children sent by the White House that drug use is a way of life," Solomon told his colleagues.
Before approving the bill, members defeated by a vote of 277-149 a motion to revise the bill to permit federal funding if local health officials determine that needle exchange programs deter the spread of HIV, do not promote illegal drug use, and would be acceptable to the local community.
Meanwhile, Health and Human Services Secretary Donna Shalala was confronted by almost 200 angry protesters in the Philadelphia area this week prior to a speech at Bryn Mawr Presbyterian Church outside the city. Organized by ACT UP Philadelphia, the demonstrators carried signs listing the names of intravenous drug users who had died from AIDS and chanted "Clinton, Shalala killed by brothers, Clinton, Shalala killed my sisters."
The protesters criticized Shalala for supporting the expansion of needle exchange programs while implementing the Clinton prohibition against the use of federal funding for them. They demanded she resign from the Clinton cabinet over the issue.
"I have a deep respect for those who disagree with the administration's decision," Shalala told reporters. "Yes, the science is there. But we made a decision not to fund the program."
Shalala encouraged activists to work on the state and local level to obtain funding for syringe exchange initiatives.
Illinois approves HIV name reporting
Over the objections of every major AIDS group in Chicago, the state of Illinois is moving forward with a requirement that health care providers report names of people infected with HIV.At a public hearing on the issue, more than 45 AIDS activists testified against the proposal.
Among those speaking at the hearing were attorneys, doctors, politicians and those infected with HIV. Philadelphia's AIDS Activities Coordinating Office held similar hearings in the city in March, where all of those who testified opposed name reporting.
"I think this rule has the potential for doing significant harm, not only to myself, but to others living in the state of Illinois," said state Rep. Larry McKeon (D-Chicago), who said he has been HIV-positive for a least a decade. "We enacted a law which makes personal privacy and the sanctity of the doctor-patient relationship the cornerstones of the state's response to AIDS, and I intend to keep it that way."
While acknowledging the need for better data collection, advocates also cited significant stresses surrounding the act of getting tested. The chief one is the fear of bad news, but not far behind is apprehension over what will be done with such personal information.
"If we have even one more obstacle to getting tested, I worry how many more people will wind up in a position . . . where they're a lot farther along in their illness than they need to be," said Scott McAllister, an infectious-disease specialist whose practice treats more than 1,000 HIV-positive patients. "The treatments that are available for HIV work well when they're applied early."
Currently, only those diagnosed with AIDS have their names reported to the Illinois Department of Public Health. Since 1981, the names of 20,679 people have been collected, with two-thirds of them having since died. Department officials estimate 32,000 people in Illinois currently are HIV-positive.
Public health officials hope to more effectively track trends in the deadly disease with better data, and connect those infected with services and early treatment, according to state spokesman Tom Schafer. Recent treatment breakthroughs that prolong the lives of HIV-positive people have increased the pressure on public health officials to better understand these new trends.
At the urging of the U.S. Centers for Disease Control and Prevention, the department in February proposed that Illinois join 31 others states that report names not only of people diagnosed with AIDS, but also those who were infected with HIV but not yet formally diagnosed.
"Without HIV surveillance, we will be increasingly unable to monitor the direction of HIV in our communities," said Dr. John Ward, chief of HIV surveillance at the CDC, who spoke at the Chicago hearing.
The new rule would require the names of those testing HIV-positive to be reported to local health departments, though an alpha-numeric identifier would be assigned before those cases were forwarded to the state health department.
Currently names are reported in cases of 60 diseases, including syphilis, gonorrhea, salmonella and cancer. There have been no breaches of confidentiality, Schafer said.
There is a continuing debate over whether name reporting actually discourages people from getting tested, citing contradictory studies.
"How long before 'the list' becomes the subject of a computer glitch, or the topic of local gossip? Can you vouch for the administrators of all 102 of the counties?" said McKeon.
Advocates suggested creating a unique identifier, perhaps one combining a Social Security number and birth date, rather than relying on a system that uses names. Two states, Texas and Maryland, use unique identifiers.
Illinois will continue funding 64 anonymous test sites, which don't report names. However, if a person who tests positive at an anonymous site later seeks treatment, his doctor would be required to report his name. Opponents think some people might forgo treatment in order to remain anonymous.
HIV still on rise, CDC confirms
Although the number of new AIDS cases in the United States has declined substantially in recent years, HIV continues to spread through the population essentially unabated, according to data released by the Centers for Disease Control and Prevention.The first direct assessment of HIV infection trends shows that the recent decline in U.S. AIDS cases is not due to a notable drop in new infections. Rather, improved medical treatments are allowing infected people to stay healthy longer before coming down with AIDS, overshadowing the reality of an increasingly infected populace.
"The findings of this report give us a very strong message, that mortality may be going down -- therapy is working -- but HIV continues its relentless march into and through our population," said Thomas C. Quinn, an AIDS specialist at the National Institute of Allergy and Infectious Diseases. "These data tell us we have a lot of work to do."
The findings also confirm previously identified trends showing that women and minorities are increasingly at risk. Especially worrisome, officials said, is that the annual number of new infections in young men and women 13 to 24 years old -- a group that has been heavily targeted for prevention efforts -- is virtually unchanged in recent years.
"It certainly documents that we have ongoing new infections in young people," said Patricia L. Fleming, chief of HIV/AIDS reporting and analysis at the CDC in Atlanta.
The report also shows continuing high numbers of new infections among intravenous drug users, a population that has recently been the focus of a political debate over the value of needle exchange programs that offer drug users clean syringes to prevent the spread of HIV.
CDC officials would not comment directly on President Clinton's decision to extend a ban on federal funding of needle exchanges. But both Fleming and Quinn said that AIDS prevention programs in this population need to be improved.
"It's clear that something stronger is needed to slow this epidemic," Quinn said.
The new figures, in the CDC's Morbidity and Mortality Weekly Report, are based on HIV test results compiled by 25 states from January 1994 to June 1997. They indicate that the number of new infections during that period remained "stable," with just a "slight" decline of 2 percent from 1995 to 1996, the most recent full year included in the new analysis.
By contrast, deaths from AIDS declined 21 percent in 1996 and dropped an additional 44 percent in the first six months of last year.
From 1995 to 1996, the number of HIV infections increased by 3 percent among women. And it jumped 10 percent among Hispanics, although officials said that figure was imprecise. Infections declined by 2 percent in the white and 3 percent in the African American populations.
All told, the study tallied 72,905 infections during the survey period. The number nationwide is much higher, since participating states account for only about 25 percent of U.S. infections.
The single biggest risk category was men having sex with other men, but heterosexual transmission continued its steady increase. Most of those cases involved women contracting the virus through sex with male drug users, Fleming said.
The survey is the first to track infection trends by looking directly at HIV test results in people coming to clinics and other health care outlets. That's a major change from the previous system, in which officials simply estimated the number of new infections by counting the number of people newly diagnosed with AIDS.
The old "back calculation" method worked fine during the first 15 years of the epidemic, when HIV infection progressed predictably to disease over a period that averaged about 10 years. With drug therapies now slowing disease progression, however, the number of new AIDS cases no longer reflects the number of new infections, and public health officials were becoming uncertain about how they were doing in prevention efforts.
The new reporting system, now spreading to other states, has helped officials regain those bearings, Fleming said. And although everyone wishes the numbers were more encouraging, she said, at least officials now have a clearer picture of the task at hand.
The CDC has not formally taken a position on whether HIV reporting should be by name or by a "unique identifier," although it has on several occasions challenged the effectiveness of HIV reports other than by name.
May Wellness schedule announced
May workshops in the "Maintaining Wellness Series" sponsored by ActionAIDS' ACT Program have been announced by series coordinator Kevin D. Greene. All workshops are participatory with pre-registration required, Greene said.This month's offerings include:
May 21 at 6:00 p.m. - 8:00 p.m.
Pressure Point Therapy
Dr. Ralph DeMarino will show you how to get rid of headaches, back and neck pain, and sinus/allergy problems using Pressure Points associated with these common conditions. He will discuss benefits of Chiropractic for people living with HIV and AIDS. If you like Pizza come early as Refreshments will be served. Remember! Pre-registration is required.
May 4, 6, 11, 13, 18, 20, 27 @ 3:00 p.m. - 5:00 p.m.
"Qi Gong Series"
"Qi Gong is the art of developing vital energy for health, vitality, mind expansion and spiritual cultivation." How can you have more energy, shake off depression, and decrease some of those aches and pains? Qi Gong! This class is powerful! Daily Practice gives best results.
Mondays May 4, 11, 18, @ 6:00 -- 7:30 P.M.
Reiki Sharing: Come experience a Reiki Treatment!
Reiki is a form of healing energy used to promote wellness. This "laying on of hands" technique will cause deep relaxation, decrease anxiety, pain, and stress.*If you are interested in learning Reiki we need to hear from you!
Thursday May 7, 14, 28 @ 6:00 - 7:30
Yoga- Energizing and Calming!
Yoga is a system of stretching and breathing that improves the flow of energy in the body when it is done as a part of your daily self care routine.
Tuesday 1998 @ 5:30 - 7:30 p.m.
"Unlimited Power" -- Tapes #16-18
Want to improve your perspective on life? Try a new experience of learning to communicate better with yourself and others. Anthony Robbins is the best selling author of "Unlimited Power," and other success focused technology. Come listen, learn and relax.
All workshops are participatory with pre-registration required. For more information or to pre-register call Kevin D. Greene, ACT Program Coordinator @ (215)981-3330. 1216 Arch Street, 6th Floor, Philadelphia, PA 19107. Monthly schedule information is on voicemail and the web: www.actionaids.org.
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