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Issue #206: December 4, 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 articles in this issue include AIDS, AIDS Treatment News, Kaiser Daily HIV/AIDS Report, New York Times, Reuters Health Information Service, United Press International.
Nine jailed in DuPont Sustiva protest
Gene may speed AIDS progression
Pittsburgh may join city in support of code reporting
Drug combo found effective in perintal HIV
High CD4 counts predict positive impact of PIs
Prison dentist's dirty drills heightens HIV risk
Man accused of injecting son with HIV
US calls drug a "first-line" treatment
Charging that DuPont Pharmaceuticals has made a "calculated decision that will keep their new AIDS drug out of the hands of people who may need it the most," nine Philadelphia area AIDS activists, including We The People's interim director, were arrested on December 1st during a demonstration at the headquarters of the pharmaceutical company in Wilmington to protest the high cost of Sustiva (efavirenz), the new NNRTI approved for the treatment of HIV disease.
The nine were among almost 250 demonstrators who, in Philadelphia and Wilmington protests, demanded that DuPont reduce the cost of the medication, which was recently approved by the U.S. Food and Drug Administration.
Organized by ACT UP Philadelphia and We The People, the protesters said that the high price of Sustiva puts it out of reach for many people living with HIV/AIDS. Several state AIDS drug assistance programs have threatened not to cover the drug unless the price comes down.
On December 2nd, US public health officials recommended that Sustiva be added to the federal guidelines for HIV treatment as a "preferred" medication, the first time that a drug other than a protease inhibitor has been added to the list. The recommendation suggests that Sustiva plus two nucleoside drugs should constitute a "first-line" therapy for the treatment of HIV infection.
The World AIDS Day protests began at Philadelphia's State Office Building, and moved in five buses to Wilmington for a confrontation with DuPont officials.
WTP interim director Rob Capone told the demonstrators that "Today is World AIDS Day. Millions of people around the globe are participating in events to raise awareness of the epidemic. They hope to politely persuade the powers that be that more needs to be done in order to stem the tide that has already taken far too many lives from us. They hope to remind the world that despite advances in treatment, many are still dying because they have no access to those treatments.
"Millions more are participating in events which mourn the passing of loved ones in quiet remembrance," Capone continued. "They hope and pray that those who have passed are in a better place and they share their pain and grief and loss with those who have the same experience.
"We The People is here today -- but not to be polite and not to passively mourn our friends and loved ones. We are here to fight for our survival. We are here because we are tired of being used as a means to expand corporate profits. We are here because we are tired of watching our friends die because of corporate greed and bureaucratic complacency."
Saying that people with AIDS are "not just mere consumers," Capone said that to companies like DuPont, people living with HIV/AUDS are "just a market niche to be exploited for increasing the bottom line."
But in fact, he said, "We are human beings that have a right to life, despite the size of our incomes. And we demand access to what we need to sustain our lives."
ACT UP's Paul Davis said that "World AIDS Day is an important reality check in our global battle against AIDS. It is certainly not a holiday, but an opportunity to look around and ask, 'Isn't there anything more we can do?' With millions of people infected worldwide, and more infected every day, it certainly seems like there must be something more we can do. Even here in the United States, new drugs are out of the reach of people without insurance or access to special programs. And now, DuPont Pharmaceuticals has made a calculated decision that will keep their new AIDS drug out of the hands of people who may need it the most."
The demonstrators claim that Sustiva is currently twice as expensive as similar drugs, priced in the range of protease inhibitors, which are more expensive and complicated to manufacture.
"DuPont will tell you that Sustiva is a powerful and important new AIDS drug," Davis continued. "We agree. But we do not agree that a good drug deserves to bankrupt public health programs and remain out of reach of millions of people with AIDS around the world."
The six largest AIDS drug assistance programs (ADAP) in the country, including New York, California, Texas, Puerto Rico and Pennsylvania, account for over 20% of the AIDS drugs sold in the nation, have decided that Sustiva will not be included in their ADAP's because of the current price. Many thousands of people depend on these programs, especially in states hardest hit by AIDS.
Dana Pierce-Hedge, the California program manager, announced that the cost of the drug is the only reason that Californians who rely on the state's ADAP will not have access to Sustiva.
"It's the cost. That's why it hasn't been added". She also said "If the price was reduced, we could provide Sustiva without endangering our program."
New York manager Lanni Kross said that "DuPont's unexpectedly high price could jeopardize our program's ability to cover important medicines for New York residents now and in the future. To ensure program safety and stability, we cannot add Sustiva to the formulary for the time being. If DuPont brought the price down to be more in line with the other drugs in its class, we could revisit this decision."
Texas manager Linda Moore said: "[The] Texas [ADAP] is facing a budget crisis. Due to the increased costs of medications across the board, the high cost of Sustiva has had a tremendous impact on our program... We are facing a deficit for the first time, and cannot cover DuPont's drug."
Pennsylvania manager Bob Stranco admitted: "We are delaying the addition of the drug while we re-evaluate our ability to pay for it. If DuPont brought the price down to be more in line with the other drugs in its class, our re-evaluation would become much simpler."
DuPont has offered a meager 5% discount on top of the legally-mandated 15% discount to the AIDS drug assistance programs. But activists at the demonstration concluded that the action is not enough.
"Ninety percent of people with HIV live in the developing world, and 95% of the 33.4 million people infected with HIV around the world will never gain access to drugs such as the one DuPont is overcharging people with AIDS for," Said ACT UP's Asia Russell.
If the AIDS crisis pandemic is a fire, then profiteering drug companies like Dupont fuel the fire every day through pricing their life extending drugs out of reach of many in the developed world," Russell said.
"DuPont must also support the call from the activist community for easing up on restrictions to patent rights for pharmaceuticals," Russell continued. "These restrictions kill people with AIDS and other diseases in developing nations by preventing countries with the technology to make their own versions of life saving, essential drugs from doing so. The truth is, these are restrictions set into place by greedy corporations who dream of sucking profit even out of nations where they never planned to market their drugs. "
When the speaches concluded the crowd circled around to the entrance to Dupont's office building and nine demonstrators sat blocking the front entrance. After about ten minuites police arrived in riot helmits and rubber gloves, opened the doors and began dragging the nine into the building. Other officers then dispersed the remaining crowd and arrested those who blocked the entrance.
After being detained for about seven hours, the demonstrators reminded the police that many needed to take medications. They were then quickly processed and brought before Justice of the Peace Rosalie O. Rutkowski and charged with loitering, disorderly conduct and "having a parade without a permit."
At the hearing, DuPont lawyers demanded that the protesters be prohibited from having "contact" with and of the company's personnel or offices for one year. Justice Rutkowski refused the request, although she prohibited any of the protesters from having contact with the Hotel DuPont, the site of the demonstration.
Capone, Davis, and two other ACT-UP members pled not guilty to the charges and will seek jury trials in the Commonwealth court of Delaware.
Other organizations participating in the demonstration included seven recovery programs: Under the Safety Net, Somerset Project, Minute By Minute, Phoenix II, Positive Steps, 12 Steps Ahead, and Anoth Day Clean.
Meanwhile, Glaxo Wellcome has announced that it will discount wholesale prices for it's new anti-HIV drug Ziagen, with further discounts for ADAP programs.
The AIDS Treatment News said that the announced price of the drug was lower than many treatment advocates had feared." The annual cost of the drug to state ADAPs will be about $3,000, according to ATN.
According to Kaiser Daily HIV/AIDS Report, Bill Arnold of the ADAP Working Group, a coalition of state ADAPs that has been pressuring drug companies to lower prices for some AIDS therapies, said, "There is some evidence today that a constructive dialogue between representatives in the HIV community and representatives from the pharmaceutical industry can result in outcomes that are in the best interest of patients with HIV and AIDS. While the issues facing ADAP programs continue to be daunting, decisions which help to contain the rising cost of AIDS drug combination therapy can only be viewed as positive."
Project Inform's Martin Delaney said, "While drug prices in general are still too high, Glaxo Wellcome is to be commended for its decision" to offer discounted prices for Ziagen.
National Cancer Institute scientists have found a genetic trait that makes people get sick sooner once they are infected with HIV.
The finding, the first to describe a gene that speeds up the progression of AIDS, may help drug designers in their search for new treatments for the deadly immune system disease, the research team said.
In the new study, researchers looked for the genetic trait in both uninfected people at high risk of getting AIDS and those who already had been infected.
People with a specific pattern in their DNA, which the scientists called PI, progressed more rapidly from being infected and having no symptoms to having AIDS.
The scientists estimate the gene is present in between 7 percent to 13 percent of the population.
Geneticist Mary Carrington says, "In the first five or six years, those individuals will progress more rapidly by a year or two." She says the gene only has this effect in the early stages of the infection.
The gene appears to play a role in the production of a molecule -- known as CCR5 -- that helps bring the virus into immune system cells. Carrington says the new research shows that "if you play around with CCR5, you're going to affect progression" of AIDS.
CCR5 caused excitement among AIDS researchers two years ago when they observed that some people were protected from the disease if they had defects in the two copies of the gene that produces the molecule.
Even a glitch in one of the two copies of the CCR5 gene could slow down the progression of AIDS, says Carrington.
The gene the scientists are reporting on in the new research is known as a promoter. It does not directly build the CCR5 protein, but it influences how much of it will be produced.
Carrington adds that another team recently published a similar finding in a different scientific journal, which supports the Cancer Institute's work.
The scientists believe that one form of the promoter gene leads to more CCR5 on the cell surface, giving HIV more doors to enter. But, Carrington says, they still have to prove this theory.
She says new drugs might aim at the promoter as a target, decreasing the production of CCR5 and slowing the disease progression.
Carrington says that people with the mutant form of CCR5 appear to still be protected from getting AIDS, even if they have the PI form of the promoter.
A report issued this week by the United Nations estimates that worldwide about 33.4 million people are infected with HIV.
Pittsburgh may join city in support of code reporting
The Allegheny County Board of Health has recommended that state officials implement a new HIV reporting requirement in Pennsylvania based on codes rather than names, joining a request made earlier this year by Philadelphia health commissioner Estelle B. Richman.
The Philadelphia Board of Health is expected to affirm Richman's position next month.
Pennsylvania officials have announced that they will soon make infection with HIV a reportable disease in the state. At present, HIV disease is only reportable when it progresses to a formal AIDS diagnosis.
The Pittsburgh Post-Gazette reports that an Allegheny County Board of Health advisory committee has recommended that the full Board support code reporting. The committee also suggests that the county, which includes the city of Pittsburgh, continue to make anonymous HIV testing available however the state ultimately decides the HIV reporting issue.
The newspaper notes that the Board of Health strongly supports some kind of HIV reporting requirement. Dr. Bruce Dixon, the county's health director, said that "effective drug treatment is slowing the rate at which HIV-infected patients develop AIDS, so counting people who are infected better reflects HIV's prevalence in the community."
A final Board of Health decision on the recommendation will not be made until a public comment period is concluded, probably by March, 2000.
Drug combo found effective in perintal HIV
Taking a combination of antiretroviral drugs during pregnancy appears to be effective at preventing the transmission of HIV from mother to child, according to a study conducted by New York researchers.
Past studies have found that AZT treatment alone can dramatically reduce transmission of HIV to an infant.
Dr. J.P. McGowan and colleagues at the Bronx-Lebanon Hospital Center in New York evaluated the safety and efficacy of combination antiretroviral therapy in 30 pregnant women who had taken a variety of antiretroviral drugs in the past.
Of the 27 infants who could be followed, none became infected with HIV. There were two preterm deliveries, and five babies weighed less than 2,500 grams, but all the deliveries were between 32 and 41 weeks gestation.
"So that's actually very good," said study co-investigator Marilyn Crane. The study was presented last week at the Infectious Diseases Society of America meeting.
One infant was stillborn, and another was born with microencephaly -- an abnormally small head. However, that infant's mother also had multiple substance abuse problems.
Most of the infants are still being followed at the family center clinic, and the oldest baby is now about 1.5 years, according to Crane.
About 50% of the women were initially on combination therapy, which included various types of nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, and protease inhibitors.
Approximately 39% had AIDS.
If a woman was not already on therapy, it was avoided in the first trimester of pregnancy, Crane said. But women who were already on therapy stayed on therapy. The goal of treatment was an undetectable viral load in the mother and prevention of HIV transmission in the infant. Among the women, 24 (80%) achieved suppression of viral load to below detectable levels during pregnancy. At the time of delivery, about one-third still had undetectable viral loads.
High CD4 counts predict positive impact of PIs
People with HIV who have high CD4 counts when they begin antiretroviral therapy with a protease inhibitor are more likely to achieve and maintain undetectable viral loads, according a multicenter team. Whether or not a patient has previously taken antiretroviral medication does not appear to significantly predict virologic response, according to the study.
In the November 12th issue of AIDS, Dr. Amanda Mocroft of the University College in London and colleagues at the University of Calgary note that factors that have been reported to be associated with virologic response include initial viral load, regimen selection and antiretroviral treatment history. The investigators evaluated the course of 243 HIV-positive patients treated at the Southern Alberta Clinic when protease inhibitor therapy first became available.
Of the 243 subjects, 180 were "drug naive" and 63 were "drug experienced." After 24 weeks of protease inhibitor therapy, 52.8% had undetectable viral loads. Patients with lower baseline viral loads and those who received more new antiretroviral drugs were more likely to have undetectable viral loads.
Within 24 weeks after the first negative viral load test, 15.5% experienced viral rebound. Dr. Mocroft's group found that "CD4 lymphocyte count at baseline was a significant predictor of viral load becoming detectable following an undetectable viral load measurement."
Treatment with the protease inhibitor Crixivan (indinavir) was associated with a greater likelihood of achieving and maintaining undetectable viral loads.
The findings illustrate the importance of regular monitoring of CD4+ cell counts, the researchers said. "They also "suggest that it is the number of new drugs started rather than previous treatment that is the important predictive factor."
Prison dentist's dirty drills heightens HIV risk
The Boston Globe has reported that a dentist working in the Albany, NY jail used unsterilized drills while working on prisoners at the jail, heightening the potential that the prisoners may have contracted HIV or other disease.
Dr. David Weinstein has been charged with professional misconduct by the New York Dept. of Education, which licenses dentists in the state.
Jail superintendent Edward Szostak expressed his surprise and confusion over the situation, noting that "a correctional facility is a place where there's a high occurrence of diseases like (HIV and hepatitis). It's a place where you want to be extra careful."
Weinstein cared for nearly 2,000 patients between 1995 and 1998. Prison officials are attempting to contact about 260 inmates who had tooth extractions during that time.
Man accused of injecting son with HIV
Missouri prosecutors have charged that a hospital laboratory technician in St. Charles deliberately injected his now seven-year-old son with HIV when he was 11 months old.
Brian Stewart is charged with first-degree assault.
Stewart's defense lawyer claims that the charges are based on circumstantial evidence, pointing out that there were two intravenous drug users also living in the same household at the time of infection and that the child may have also come into contact with two convicted sex offenders.
But prosecutors argue that health officials have tested everyone who may have come into contact with the boy and that none have tested positive for the virus and that there are no signs the child was sexually abused.
Prosecutors assert that Stewart did not want to support a child and inoculated the boy with infected blood.
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