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In This Issue:
New warning on ddI, pancreatitis
Health programs do well in budget bill
Congress approves disability insurance bill
HIV infections now total 50 million worldwide
Medical marijuana activists plead guilty
Homeless, poor moms at increased risk of HIV
'Hot Tracks' takes to the telephone
ActionAIDS "Art for Life" set for Tuesday
U of P sets World AIDS Day event
City officials and other invited guests will join We The People on World AIDS Day to open "We The People West," the coalition's second neighborhood-based resource center for people living with HIV/AIDS in Philadelphia.
Jannie Blackwell, in whose City Council District the project is located, will deliver opening remarks at the event, to which other city officials have also been invited.
The grand opening of We The People West and the Arnold Jackson Memorial Clinic will be held on Wednesday, December 1, 1999, at 11:00 a.m., at 4016 Lancaster Avenue.
We The People West is part of a major new initiative developed by the city's AIDS Activities Coordinating Office to bring AIDS services to low-income neighborhoods which have been underserved by AIDS services since the beginning of the epidemic. As the first "storefront" AIDS service center in Philadelphia, We The People has been asked to develop new sites in West Philadelphia and in the city's Kensington section. The Kensington site is expected to open in early 2000.
The "storefront initiative" is a multi-agency collaboration that has been formed by WTP which also involves Blacks Educating Blacks About Sexual and Health Issues (BEBASHI), the Jonathan Lax Treatment Center, Philadelphia Community Health Alternatives (PCHA), One Day At A Time, and Prevention Point Philadelphia. Together, these agencies will offer a variety of HIV prevention and care services including HIV counseling and testing as well as primary medical care to uninsured and underinsured persons living with HIV/AIDS.
This is the second major effort led by We The People to assist West Philadelphia in helping people with HIV/AIDS in their community this year. Marlton Residences, a 25-unit affordable rental housing complex designed for occupancy by people living with HIV/AIDS, opened in July only a few blocks from the new center.
Charles Starnes, WTP Board Chairperson, noted that WTP has long recognized the need to provide services in the communities most heavily impacted by HIV disease.
"We have been advocating for neighborhood based services for years and I am pleased that the City's AIDS Activities Coordinating Office has finally been able to find the resources to help in this effort. This project is the beginning of a new era for WTP, one where we officially become a 'hybrid' between an advocacy group and a professional health and social service organization."
WTP has received over $415,000 in Ryan White Care Act funding to expand its neighborhood-based activities. The project is unique in that it provides for a variety of peer and professional services in a non-traditional low demand atmosphere. All services are offered on a walk in basis and the service delivery model incorporates a peer-based approach blended with professional care services.
Rob Capone, WTP Executive Director, said that it is particularly appropriate that the new program be led by people living with HIV/AIDS themselves. "I am excited about this project. We are the experts in peer based drop-in type services; we have been doing it for over ten years and our partners are equally experienced in their professional care services. This project represents an evolution for WTP which will greatly increase our ability to help our own," Capone said.
Capone said that WTP is pleased to be able to officially open on World AIDS Day.
"We have a history of honoring our brothers and sisters who have passed by taking action on this day, to help those still struggling to survive. This year, while many around the world gather to emphasize the need for increased access to care, WTP will again take action with the opening a new facility designed to do just that for the first of two Philadelphia neighborhoods."
We The People has for many years been the largest regional coalition of people living with HIV/AIDS in the nation, and is by far the largest AIDS service organization comprised primarily of people of color in the region.
A revised warning letter, which expands the number of patients at risk of fatal and non-fatal pancreatitis associated with didanosine (ddI, Videx), has been sent to healthcare providers by Bristol-Myers Squibb, the maker of the nucleoside analogue reverse transcriptase inhibitor.
The original warning of a 1% to 10% risk of ddI-related pancreatitis, included in the drug labeling when ddI was approved by the FDA in 1991, was based on phase III experience with patients with advanced HIV infection who were taking higher than the recommended doses of ddI.
The new warning comes as a result of pancreatitis deaths in patients participating in a trial of ddI and d4T (stavudine) with or without hydroxyurea. "These deaths occurred both in patients who were treatment-experienced and treatment-naive without significant immunosuppression, and at the recommended doses of didanosine and stavudine," the letter states.
Specifically, two treatment-naive patients died of pancreatitis about 7 months after beginning triple therapy with ddI, d4T and a protease inhibitor.
Another two pancreatitis deaths occurred in treatment-experienced patients participating in the ACTG 5025, which involved a regimen of ddI, d4T, indinavir and hydroxyurea. These two patients were hospitalized for pancreatitis within 3 months of trial enrollment and died between 1 and 10 weeks of diagnosis. The ACTG 5025 has since been cancelled due to unacceptable toxicity levels.
"All of these patients had CD4 >500 cells per microliter and HIV RNA <200 copies/mL," the letter continues. However, Bristol-Myers Squibb officials point out that three of the four patients who died had other risk factors for pancreatitis. (Reuters)
The year-long budget war between Congress and President Clinton over funding the government has ended with many health programs in the Department of Health and Human Services (HHS) coming away with big increases.
The omnibus appropriation measure approved by Congress includes the measure that funds HHS, as well as the Departments of Labor and Education.
One of the biggest winners was the National Institutes of Health, popular with Republicans and Democrats alike. The final bill appropriates $17.9 billion for NIH, up $2.3 billion from the previous year. But for budget "scoring" reasons, $3 billion of that total will not be available until Sept. 29, 2000, the last day of the fiscal year.
The "advance funding" bothered several lawmakers, who said that it could interfere with NIH activities. "Medical research is not a faucet that can be turned off and on," complained Rep. Louise Slaughter, (D-NY). "No disease will wait for a clinical trial to get to the next round of funding. A colony of bacteria is not going to hibernate until the researcher receives the promised grant," she said.
Also set for a major increase is the Centers for Disease Control and Prevention, whose fiscal 2000 appropriation of $2.96 billion represents an increase of $190 million from last year's total. Ryan White AIDS programs will receive $1.59 billion, up $184 million from last year
Other health programs receiving boosts are Community Health Centers, up $49 million to $1.02 billion; health professions programs, up $42 million to $344 million; the Maternal and Child Health Services Block Grant, up $15 million to $710 million; the Title X Family Planning Program, up $24 million to $239 million; and the soon-to-be-renamed Agency for Health Care Policy and Research, up $27.1 million to $200 million.
Among those "losers" in the bill is the Ricky Ray Hemophilia Relief program. While the program will receive an appropriation of $50 million, its backers were hoping for the full $750 million Congress authorized last year to provide payments to hemophiliacs who acquired HIV through contaminated clotting factor. "We may have to string it out over a couple of years," said one Appropriations committee staffer.
The omnibus spending bill also includes language that would reinstate the "Mexico City" policy barring US aid to international family planning organizations that use their own funds to support abortion rights. And it includes the $17 billion Medicare "giveback" bill that would restore to a variety of health care providers some of the cuts imposed by the 1997 Balanced Budget Act. (Reuters)
Congress has finally given approval to legislation that would make it easier for those with disabilities, including people living with HIV/AIDS, to return to work without losing their health insurance.
The bill was left for dead several times over the last days of the Congressional session as negotiators struggled to agree on how to pay its estimated $800 million, 5-year cost. But the final version of the "Work Incentives Improvement Act" would allow those with disabilities receiving Medicare to continue that coverage for 4.5 years longer than current law allows if they resume working, and would let those receiving Medicaid "buy in" to that program if their incomes rise beyond current eligibility thresholds.
The final version of the bill would also provide $250 million for a "demonstration" program to allow Medicaid to cover those with degenerative diseases such as HIV or multiple sclerosis who do not yet meet the definition of disabled.
Approved by the Senate 95-1 and by the House by 418-2, the measure represents a major win for President Clinton, in that it was one of his top legislative priorities for the year. But when he signs the bill, probably sometime in early December, the president will also have to swallow something he opposes - unrelated language inserted at the last minute that would extend by 90 days a Congressional moratorium on controversial rules to rewrite the system for allocating organs for transplant.
Still, White House health advisor Chris Jennings said that the President was pleased with the final bill. "That is a very, very big victory for the president," Jennings said. "It is an important, bipartisan initiative that is long overdue."
Congressional sponsors were also pleased. The bill, said Senator James Jeffords, (R-VT), "...provides us the opportunity to bring responsible change to federal policy and to eliminate a misguided result of the current system - if you don't work, you get health care; if you do work, you don't get health care. The Work Incentives Improvement Act of 1999 makes living the American dream a reality for millions of individuals with disabilities, who will no longer be forced to choose between the health care coverage they so strongly need and the economic independence they so dearly desire." (Reuters)
People who begin an anti-AIDS drug combination therapy soon after being infected with HIV show signs of joining a select group of HIV-positive patients who seem never to develop full-blown AIDS, a study just released suggests.
The research, conducted in Boston, also indicates that patients can boost the strength of their immune systems by temporarily discontinuing the powerful drug cocktail known as highly active antiretroviral therapy, or HAART.
The findings could have important implications for HAART, a drug combination with disturbing toxic side-effects. Recent surveys show HAART has only a limited effect in suppressing the spread of HIV in long-term treatment.
"We looked at the results of aggressive treatment with HAART as early as possible after people are infected with HIV," said Dr. Eric Rosenberg, instructor of medicine at the Massachusetts General Hospital and Harvard Medical schools.
His report, presented at a meeting of the Infectious Diseases Society of America in Philadelphia, covered 21 patients with acute HIV-1 infections who underwent therapy before their body had begun to produce HIV antibodies, an event known to physicians as seroconversion.
HIV infects immune system cells known as CD4 T-cells, takes over the cells's machinery and uses it to replicate itself. When this happens, the body's other immune cells detect the activity and move in what Rosenberg termed a "T-helper cell response."
"After therapy was begun, all but two patients developed HIV-specific T-helper cell responses similar to those seen in so-called 'non-progressors' -- that handful of untreated people who get HIV but never progress or progress very slowly to full-blown AIDS," Rosenberg said.
The research suggests that people at risk for AIDS can dramatically improve their ability to stave off HIV if they begin HAART treatment at the first signs of HIV infection, characterized by mild flu-like symptoms that occur several weeks after exposure to the virus and before seroconversion.
"At-risk individuals who suffer flu-like symptoms should be sure to tell their doctors if they suspect they have been exposed to HIV and undergo both a standard HIV test that measures antibodies against HIV and a test that measures the HIV viral load in the bloodstream," Rosenberg said.
"If the first is negative and the latter is positive, they may benefit from prompt initiation of antiretroviral therapy," he added.
His research also showed that two patients who discontinued HAART after a year of treatment saw a significant improvement in their immune systems after they stopped taking the drugs, and later when the HIV virus again became detectable and they resumed the drug therapy.
"We theorize that T-helper cell responses may be significantly augmented with structured treatment interruptions in persons who are caught very early after infection and treated with potent therapy," Rosenberg said.
That could be good news for people on the HAART regimen who must take dozens of pills each day simply to stay alive and healthy.
While the drug combination therapy has helped stop HIV patients from developing AIDS, the treatment can have side-effects ranging from weight loss, nausea, vomiting and abdominal pain to a strange redistribution of fat called hyperlipodystrophies or "buffalo hump."
The advent of HAART was accompanied by a steep decline in the number of AIDS deaths, which fell 42 percent from 1996 to 1997. But the U.S. Centers for Disease Control and Prevention has reported a smaller 20 percent decline between 1997 and 1998, while HAART therapy recipients find the treatment no longer works after a while. (Reuters)
The number of cases of HIV infection worldwide has reached the 50 million mark, according to a report released by the World Health Organization and the Joint United Nations Program on HIV/AIDS (UNAIDS). As of 1999, more than 16 million of these individuals have died, the organizations said.
The number of people who have been infected with HIV is nearly equal to the entire population of the United Kingdom, Dr. Peter Piot, UNAIDS executive director, pointed out at a press conference in London, where the new statistics were made public.
The report estimates that, in 1999, there have been 5.6 million new cases of HIV infection worldwide in adults and children. That's about the same as last year, but there have been a record 2.6 million deaths from AIDS this year. Piot pointed out that in many countries, AIDS is now the single greatest threat to economic development.
Another global trend is an increase in the number of HIV-infected African women, who now outnumber HIV-infected men there by more than 2 million. Sub-Saharan Africa is still the "global epicenter of the epidemic" where the spread of HIV infection continues unabated, Piot said.
The increase in new HIV infections is particularly steep among young African girls. "African girls aged 15 to 19 are five to six times more likely to be HIV-positive than boys of the same age," according to WHO and UNAIDS officials.
"Although the numbers are still low in the former Soviet Union, with 95,000 people newly infected this year, there are now 360,000 people infected, which is double the number (reported) in 1997," Piot said in the press conference.
However, there is also some good news, he said. "A number of countries and regions are managing to keep the number of new infections low."
For example, "Thailand is sustaining the downward trend in new infections. We were very concerned about the impact of the economic crisis, but it seems that the downward trend is continuing."
The Philippines is another country that has had some success, in that the low rates of HIV infection there have been maintained. "We need to see more low-prevalence countries making more effort to keep the prevalence low before a crisis hits," Piot commented.
"I think we are now at a turning point in the nearly 20-year history of the AIDS epidemic in Africa," he added. "Everywhere I go, I hear the top African leaders speaking out about AIDS. They see this now as the major threat to the continent's development -- and that's a welcome change."
Additional financial commitments to fighting AIDS in the developing world have been made recently by the US and the UK, which is a good sign, he noted.
But Piot called for more efforts to access "untapped resources, such as debit relief operations." UNAIDS is currently working with the World Bank to see that some of the funds targeted for social programs will go to AIDS campaigns.
Claiming that President Bill Clinton plans to "celebrate World AIDS Day by denying AIDS drugs to PWAs in developing countries" through its world trade policies, ACT UP and other activist groups will sponsor a November 30th demonstration at the White House as well as other protests at the meeting of the World Trade Organization (WTO) in Seattle early December..
According to a press release, the group estimates that 600 people will march and rally Tuesday, "demanding an end to US policies that threaten and enforce sanctions against countries utilizing legal methods for accessing essential medications."
The group will march from the headquarters of Bristol-Myers Squibb, a major manufacturer of AIDS drugs, to the White House "to leave visual evidence of big business and Clinton Administration collaboration on restricting AIDS drug access through US trade policy & WTO regulations."
The demonstration will include a solemn mock "funeral: at the White House, where it will seek to dramatize the human toll of US AIDS drug policies.
The release says that a gospel choir will present a "Golden Urn Award" to Bristol-Myers and Clinton Administration ":for contributing to AIDS death rate that has lowered life expectancy by 10-25 years in African nations."
At the protest, a report will be released which describes what ACT UP calls "case studies of US interference with treatment access in South Africa, Thailand and other nations; Clinton officials placing drug company lobbyist concerns over public health and intl trade law in bilateral and WTO negotiations; analysis of inflated AIDS drug prices designed to gouge 1st World markets."
The demonstration will begin at 12:15pm at the offices of Bristol-Myers Squibb, 655 15th Street, NW (@ F. Street), in Washington. At 12:30pm, the group will proceed to the Pennsylvania Avenue entrance of the White House.
For the past year, US activists have opposed US efforts to prohibit compulsory licensing (off-patent production) and parallel importing (purchasing through a third party country) of pharmaceuticals.
After confrontations with Vice President Gore on the campaign trail and large protests in NY, DC and Philadelphia, the Clinton administration reversed its position on the South African law allowing these measures. Activists are demanding that the stated deal with South Africa - acknowledging that compulsory licensing and parallel importing of essential medicines should not be prosecuted by the US - become the global policy for US trade negotiations.
This month, the Thai government filed suit against Bristol for strong-arming patent extension on ddI.
"The Bristol Myers CEO took home $147 million in one year alone. They give $100 million to five African nations in a controversial PR move that will not provide a single pill and was opposed by public health officials in several countries.," explained Lee Scott of ACT UP. "Our government helped Bristol block generic production of ddI, an AIDS drug, and taxol, a cancer drug, in Thailand."
"We finally did the right thing for South Africa," said ACT UP's John Bell, who is also a member of the board of directors of We The People. "But saving lives in Thailand, Brazil and India is just as vital as saving lives in South Africa. The US must cease interference with legitimate steps to get lifesaving drugs to people with HIV."
Other World AIDS Day efforts for access to medication are taking place in South Africa, Thailand, Brazil, New York, and Washington DC.
Barred from using medical necessity as a defense, two prominent marijuana advocates have pleaded guilty to reduced drug charges in a Los Angeles federal court.
The pleas by Todd McCormick and Peter McWilliams followed a judge's earlier ruling that the pair could not refer to California's medical marijuana initiative or to their own medical conditions in their upcoming trial.
McCormick, 29, suffers from bone cancer, and McWilliams, 50, a self-help book publisher, is a wheelchair-bound AIDS patient.
They were accused of growing more than 4,100 marijuana plants at a rented Bel-Air mansion and trying to sell their crop to the Los Angeles Cannabis Buyer's Club, which has dispensed the drug since California voters passed Proposition 215 in 1996.
The federal government does not recognize the state initiative as binding. Nor did U.S. District Court Judge George H. King in a Nov. 5 opinion that devastated the defendants.
McWilliams' lawyer, Tom Ballanco, said Friday that King's ruling "took away every defense we had," leaving McWilliams facing certain conviction and at least 10 years behind bars.
"He couldn't survive a sentence like that," he said.
McCormick, whose legal bills are paid by actor Woody Harrelson, said that pleading guilty will give him a chance to remain free on bail while his lawyers appeal King's ruling on a medical necessity defense.
"If I would have been found guilty at trial, I would have been remanded into custody and not allowed an appeal bond," he said. "I felt this was the smartest way to protect my health and my well-being and my rights in an appellate process."
After issuing his earlier ruling, King pressed both sides to negotiate a plea agreement rather than go to trial.
In the end, the prosecution dropped marijuana manufacturing charges carrying a mandatory minimum sentence of 10 years in prison.
McWilliams and McCormick were allowed to plead guilty instead to conspiring to grow and distribute marijuana, punishable by a maximum five years imprisonment.
McCormick agreed to a flat five-year prison term and McWilliams faces a term of up to five years when they are sentenced on Feb. 28.
Thom Mrozek, a spokesman for the U.S. attorney's office, called the pleas a victory for the prosecution.
"This is the first time that these defendants have acknowledged they were producing marijuana for commercial gain," he said.
Indeed, the agreements they signed make no mention of growing marijuana for medical use.
McWilliams, owner of Prelude Press, admitted financing the marijuana growing operation and paying McCormick more than $120,000 in one year.
According to court documents, McWilliams hoped to strike it rich as a marijuana grower and compared himself to Microsoft founder Bill Gates.
In a letter to McWilliams memorializing their partnership, McCormick wrote that the deal entailed "us splitting the harvest three ways, you receiving two thirds for providing space and equipment and me receiving one third for labor and expertise."
Both men were arrested after agents from the Drug Enforcement Administration raided the mansion on Bel-Air's Stone Canyon Drive, confiscating 4,116 marijuana plants.
Alan Isaacman and David Michael, McCormick's lawyers, said Friday they cannot appeal King's ruling barring a medical necessity defense until after the scheduled Feb. 28 sentencing.
McWilliams, meanwhile, said he hoped the judge would "consider my situation. This has been a terrible ordeal. I've lost my health, I've lost my business and I'm about to go into bankruptcy. I'm just exhausted." (Los Angeles Times)
Although 39% of homeless and low-income housed mothers are at high risk of HIV infection, 75% of these women report that they have "no or low risk of contracting HIV," according a report by Massachusetts researchers.
Dr. Linda Weinreb of the University of Massachusetts Medical School in Worcester and associates interviewed 220 homeless and 216 low-income mothers living in the area. They collected data on the subjects' demographic and psychosocial factors, along with HIV-risk practices.
Overall, Dr. Weinreb's group found that both groups of women to be at increased risk of HIV infection. "A history of childhood victimization, adult partner violence, or both placed [these] women at a significantly increased likelihood of high HIV-risk practices," they report in the November issue of The Journal of Family Practice.
Other factors that were significantly associated with high-risk behaviors included "African American race, knowledge about HIV, and self-perception of risk."
Although both groups of women had adequate knowledge about HIV-related risk practices, they tended to underestimate their own risk. "Only 14% of high-risk women correctly perceived their own risk as being medium or high."
The authors conclude that HIV prevention services need to target "homeless women, specifically, and extremely poor women in general."
"For extremely poor mothers, the risk of contracting HIV infection is one of many immediate threats to their survival," Dr. Weinreb's group points out. They believe that this must be taken into consideration in designing HIV interventions for prevention efforts to be successful.
Hot Tracks, a new collaboration project between AIDS Services in Asian Communities (ASIAC), the Colours Organization and the Gay and Lesbian Latino AIDS Education Initiative (GALAEI), was recently approved for funding by the Centers for Disease Control under a special initiative for AIDS prevention activities directed to the communities of gay men of color.
The primary objective of the program is to provide gay men of color an easily accessible resource, the telephone, for them to retrieve vital resource and referral information to maintain their seronegative status and reduce the risk of HIV transmission among those living with HIV infection.
Hot Tracks is a unique HIV/AIDS prevention collaboration of the three Philadelphia organizations whose primary constituencies are African American, Asian and Pacific Islander, and Latino communities of men who have sex with men. These organizations have come together to address the information barriers to the effective inhibition of new HIV infection in their respective communities. Recognizing that homophobia and other factors have often led to the isolation and disenfranchisement of sexual minority people of color from the care and support of even their own ethnic communities, partner organizations have been and remain dedicated to the "communal" concept for their constituencies.
The primary strategies of Hot Tracks include individual and group-level interventions through an HIV/AIDS prevention telephone line providing resource and referral, individual counseling, group support, and education through the work of on-phone Health Education Counselors.
The project recognizes that a key communication tool of the targeted gay men of color is the telephone, a non-threatening and non-intrusive instrument to facilitate networking and information exchange. This allows callers to retrieve education, referrals and resources anonymously and easily. The targeted population will also be able to engage in group counseling through conference calling that is facilitated by project staff of the specific ethnic community. Group sessions will be educationally specific around key HIV/AIDS prevention subjects.
The lead applicant for the project, the Colours Organization, will oversee the cooperative effort. ASIAC and GALAEI are the leading collaborating groups.
The partnership is the second major collaboration among the region's groups serving gay men of color. Almost three years ago, the three groups, along with Unity, Inc., and We The People, formed The Village Project, another CDC-funded initiative which provides prevention case management services to over 100 gay men of color annually.
For more information, call Colours at 215=496-0330.
ActionAIDS will sponsor Art for Life: A Fine Arts Auction and Reception, on Tuesday, November 30, 1999, at Independence Blue Cross, 44th Floor, 1901 Market Street. Blue Cross is co-sponsoring the event.
The event is managed by Heisman's Art Gallery, with art at different price ranges from $20 to the thousands. "We enjoy the art that night and remember what we have lost the next day on World AIDS Day," the group said in a statement.
Tickets to the event are $25, and are available at the door.
The Penn Interdisciplinary Dialogue on AIDS will sponsor its 12th Annual World AIDS Day "Rally on the Green" on Wednesday, December 1st, at 12 noon in front of Van Pelt Library, off 34th and Walnut Streets. For more information, please contact Tonya Nicole Taylor at the University of Pennsylvania African Studies Center at 215-898-6971 or tonyat@sas.upenn.edu.