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 Bay City Newswire, Chicago Sun-Times, Nature Medicine, New York Times, and Washington Post.
State to extend deadline for HealthChoices
Clinton may extend Medicaid benefits for PWAs
ACT UP protests at drug trade show
Project Inform to provide treatment update
Nasal AIDS vaccine shows promise
Settlement could lower drug prices
TPAC reorganization stalled by committee
SF AIDS Ride embroiled in controversy
State to extend deadline for HealthChoices
State Welfare Secretary Feather O. Houstoun has announced that Medicaid recipients will have an additional two months to sign up for one of the managed care plans which begin providing Medicaid services as of July 1st.
The new deadline for joining a Medicaid managed care plan is August 20th.
HealthChoices requires all Medicaid recipients to join one of four health maintenance organizations -- Keystone/Mercy, HealthPartners, Healthcare Management Alternatives, and Oxford/OakTree -- in order to receive Medicaid benefits. Originally, the deadline for joining a plan was June 18th.
Under the new timetable, anyone who does not pick a health plan by August 20th will be forced into a plan of the state's choosing.
Advocates for people with HIV/AIDS have long called for a delay in the "automatic assignment" process, since many people with HIV/AIDS are still unaware of which AIDS specialists belong to which health plan. At a meeting earlier this week, city health commissioner Estelle Richman asked the four HMOs to pay for a mailing to all 450,000 eligible Medicaid recipients advising them on how they can obtain a list of AIDS specialists.
Most women and children with HIV joined HealthChoices last February. Other disabled individuals become part of the managed care system as of July.
In a statement, Houstoun said that 75% of those expected to pick a plan by June 18th had already done so, but that about 50,000 people still had not selected. "The two-month extension will give us additional time over the summer to work with community and low-income advocacy groups to enroll as many of the remaining 50,000 people as possible."
Houstoun also noted that Medicaid participants who are "automatically assigned" an HMO on August 20th will still be able to change to another plan later if they desire.
Information on signing up for a HealthChoices HMO is available by calling 1-800-440-3989.
Clinton may extend Medicaid benefits for PWAs
The Clinton Administration has announced that it will soon propose expanding Medicaid to cover low-income people who have been infected with HIV even if they do not show any symptoms of the disease,, according to a report in the New York Times.
Officials said they would expand coverage under Medicaid by using authority they already have to conduct and approve state demonstration projects. The administration would not be required to ask Congress to change the existing Medicaid law.
Current law allows patients to qualify for Medicaid only after they have developed AIDS and are defined as "disabled" by the Social Security Administration. Because of these restrictions, people in the earlier stages of HIV infection often are unable to pay for costly new drugs that can block development of AIDS.
Federal officials are allowed to approve experimental state programs that broaden Medicaid eligibility under section 1115 of the Social Security Act. However, the federal government generally requires state programs to show that such experiments will not increase Medicaid spending over a five-year period. Administration officials acknowledged that it may be more than five years before financial benefits are recognized. Two percent of this year's $173 billion Medicaid budget will be spent on treatment of AIDS.
Federal officials are encouraging states to submit applications for the demonstration program, and will not limit the number of projects. It is not known whether Pennsylvania, which recently implemented its HealthChoices Medicaid managed care program, will submit an application.
Congressional Republicans are generally unaware of the plan and have not criticized it, according to the Times.
Research has shown that new AIDS drugs, including protease inhibitors, are the most effective to date in halting the progression of AIDS. However, the cost of the drugs, from $8,000 to $16,000 a year, can be prohibitive for many low-income people. Additionally, some Medicaid patients have lost their coverage as a result of drug therapy, even though they need to continue taking the drugs to keep the virus suppressed. By allowing Medicaid to pay for the early treatment of AIDS, the government could save money by reducing the need for hospital care and by reducing the spread of the virus, according to Administration officials.
Vice President Al Gore originally requested the studies that led to the new proposal. He said, "Our view is that getting these drugs to people earlier won't cost more in the long run. It may even save money. It will certainly save lives." Other officials concurred, citing the public health benefits of the program.
ACT UP protests at drug trade show
On Saturday, May 31st, 300 hundred AIDS activists from New York, Philadelphia and Cleveland protested and participated in a giant die-in inside the Jacob Javits Convention Center, site of the POZ Life Expo, a major AIDS trade show and exposition traveling the United States.
Carrying placards proclaiming, "Release experimental drugs now" and "No lotteries, no limits, no lies", demonstrators demanded that AIDS drug companies make available promising experimental AIDS drugs now in development for people living with HIV/AIDS who have not been helped by current state-of-the-art AIDS therapies. Said ACT UP's Mark Hannay, "Many people with AIDS have managed to stay alive by keeping one step ahead of HIV. As the virus becomes resistant to one drug, they move onto the next one, in a never-ending battle to stay alive."
One drug company, Glaxo-Wellcome, maker of AZT and 3TC, withdrew from the Expo due to activist pressure. According to their public statement, "With the actions planned against the company at the New York Expo... the company elected to forego participation." The company is being pushed by many AIDS organizations to release its new experimental drug 1592 and its experimental protease inhibitor to people with AIDS who have exhausted their treatment options by making them available in expanded access programs.
Glaxo-Wellcome will make 1592 available only to 2500 people worldwide. This is down sharply from the 32,000 people who received the 3TC when it was still an experimental drug.
"Glaxo is trying to eliminate expanded access programs that have kept thousands of us alive this far," commented ACT UP's Mark Milano. "Expanded access programs keep people alive a few months or a year - and maybe by then there's another treatment that will help."
"Drug company greed and obstinance is once again threatening the lives of thousands of people desperately ill with AIDS. They used to release new drugs prior to approval, but suddenly, over the past year and a half, the companies won't make their promising new experimental drugs widely available anymore," said Milano. "While newly-approved therapies have indeed provided hope for tens of thousands of people living with AIDS, unfortunately many others have not benefited from these drugs, and they now need access to even newer forms of treatment."
Under pressure from AIDS activists, drug companies since the late 1980s have made promising, experimental drugs available to people who have failed conventional forms of treatment. Many people's lives have been saved or ameliorated as a result. However, with the recent release of the new AIDS drugs which have benefited many people living with HIV/AIDS, many drug companies have begun to severely restrict their expanded access programs for their even-newer AIDS drugs now in development. Patients and doctors now have to submit much paperwork and meet stringent criteria for a sharply decreasing number of program slots. Activists claim that drug companies simply want to maximize profit from their current AIDS drugs, and are delaying pursuit and distribution of better, newer drugs.
Other companies targeted at Saturday's demonstration included Abbott Laboratories and Gilead Sciences. Abbott Laboratories previously had a tiny expanded access program of less than 1000 for its protease inhibitor, Ritonovir , allegedly because of its limited availability, but the company had sufficient stores of the drug to supply the drug to nearly every pharmacy in the nation within two weeks of its extraordinarily fast approval by the FDA. Abbott is developing a more powerful protease inhibitor, ABT 378, that activists want in expanded access by fall of 1997.
Gilead Sciences has a drug in development that has already been put into hundreds of people, yet it too has no expanded access program.
Activists indicated they have been meeting with various drug companies, including Glaxo-Wellcome, to discuss how to resolve this crisis, but that the manufacturers had offered little in the way of improvement. ACT UP members indicated they would continue targeting drug companies at other trade fairs and conferences until their expanded access programs were improved and expanded.
Project Inform to provide treatment update
Project Inform, Project TEACH, Philadelphia FIGHT, and ACT UP/Philadelphia, are sponsoring a reception on Tuesday, June 10th from 6:00-7:00 pm at the Graduate Hospital Auditorium, 18th and Lombard Streets in Philadelphia. The reception will be followed by Project Inform's town meeting from 7:00-9:00 pm, which will feature a presentation on the most up-to-date treatment advances and the areas where much research is still needed.
This reception is intended to bring advocates from the region together to meet each other and discuss local, state, and federal policy issues. During the reception, Martin Delaney will present a brief overview of the major issues facing us this year and what advocates need to do to make a difference. For more information, call Julie Davids at (215) 985-4448.
Nasal AIDS vaccine shows promise
Chimpanzees inoculated with an experimental AIDS vaccine have successfully fought off repeated exposures to HIV up to a year after they were vaccinated, a research team has reported. The novel vaccine, which consists of a series of nasal sprays followed weeks later by a booster shot in the arm, is the latest addition to a small but growing arsenal of experimental AIDS vaccines showing early signs of promise after many years of mostly disappointing results.
Scientists cautioned that other vaccines have looked similarly effective in chimpanzees, only to fail in human clinical trials. But researchers said they were encouraged by the strength of the immune response triggered by this vaccine, and especially impressed with its ability to confer protection so long after vaccination.
In previous tests of AIDS vaccines, chimps or monkeys have been exposed to HIV, soon after they were vaccinated -- an unrealistic scenario. The new vaccine worked even when chimps were challenged with a big HIV dose 50 weeks after they were vaccinated -- longer than has worked in any other study.
Unfortunately, several researchers said, the company that helped develop the vaccine -- Wyeth-Ayerst Research of Radnor -- has, like other vaccine developers, been questioning the cost-effectiveness of ushering its vaccine through the expensive and time-consuming labyrinth of clinical trials and regulatory approval. Key Wyeth scientists who spearheaded the work have been removed from the project, leaving its future uncertain.
Given the latest chimpanzee results and President Clinton's recent call for a renewed national commitment to developing an AIDS vaccine within the next decade, however, scientists said they hoped the company would reconsider financing the necessary work that could lead to early safety tests in human volunteers.
"There is no doubt that a good percent of the pharmaceutical industry, for reasons that are in part understandable and obvious, have become in recent years less interested in financing development of an AIDS vaccine," said Robert C. Gallo of the Institute of Human Virology in Baltimore, who co-discovered HIV and was involved in the latest chimpanzee studies. "It's possible, and we hope it's true, that these and other recent promising findings will renew their interest."
The new vaccine was made from an adenovirus -- a kind of virus that can cause colds in people -- that was genetically engineered to contain an extra gene called gp160, normally found only in HIV. When sprayed into the nasal passages of chimps, the modified virus settled into the animals' upper respiratory tracts and intestines.
During the next week or so, the viruses multiplied in the chimps' mucous membranes, and spewed out gp160 proteins. As predicted, the chimps' immune systems responded to the HIV proteins by making antibodies and white blood cells programmed to attack HIV.
The researchers boosted that protective immune response by giving the chimps a shot in the arm containing laboratory-made versions of a different HIV protein, gp120. More than 11 months later, they subjected the chimps to intravenous infusions of HIV.
Robert-Guroff and her colleagues reported in the June issue of Nature Medicine that unvaccinated chimps became infected with the virus within a month, but vaccinated chimps remained healthy and apparently uninfected until the study ended, almost a year later.
Adenovirus-based vaccines have a potential advantage over other kinds of AIDS vaccines because adenoviruses can stimulate a potent immune system response in mucous membranes, including the urinary tract, and vaginal and rectal tissues. "We'd like to induce mucosal immunity," Robert-Guroff said, "because worldwide, transmission of HIV is predominantly across mucosal barriers" through intercourse, rather than by intravenous infection.
The new report does not specifically reveal whether mucosal antibodies were generated in the chimps, but the U.S. military has given soldiers oral adenovirus vaccines for years to protect against upper respiratory tract infections, generating mucosal immunity and very few complications.
Nonetheless, researchers warned, any AIDS vaccine made from a live virus that is capable of causing disease in people, as adenoviruses can, will have to be tested carefully for safety. Several said they hoped that will happen soon.
Settlement could lower drug prices
Prescription drug prices could take a tumble now that the 7th U.S. Court of Appeals has upheld a settlement that calls for pharmaceutical firms to charge drugstores the same prices as hospitals and health maintenance organizations, a lawyer said.
The appeals court dismissed an appeal by 11 companies that disliked a June, 1996, lawsuit settlement approved by U.S. District Judge Charles P. Kocoras.
It calls for the defendants to pay $351 million to 41,000 pharmacies and allow them to qualify for discounts offered to HMOs, hospitals and mail-order retailers.
"Based on that, we project a 20 percent savings for our consumers," said lawyer David A. Melnick, who represents 40,000 pharmacies that sued drug manufacturers.
Under the deal, drug manufacturers agreed to offer pharmacies the same discounts they already give to HMOs and others if the pharmacies can prove they have the power to persuade doctors and patients to switch brands.
The 11 defendants are American Home Products Corp.; Bristol-Myers Squibb Co.; Glaxo Wellcome PLC; Eli Lilly and Co.; Knoll Pharmaceutical Co.; Merck & Co.; Pfizer Inc.; Schering-Plough Corp.; SmithKline Beecham PLC; Warner-Lambert Co.; and Zeneca Inc.
Melnick said 11 other companies that did not participate in the settlement are awaiting trial, including Ciba-Geigy and Abbott Laboratories.
TPAC reorganization stalled by committee
The executive committee of the Philadelphia AIDS Consortium has delayed implementation of a plan to implement the group's second reorganization in as many years, after concerns were raised about a requirement from state officials that representatives of AIDS service provider agencies be removed from its board of directors.
The TPAC board of directors acts as a "regional planning coalition" for the state health department in determining priorities for and allocating almost $5 million in state AIDS funds.
Three years ago, state officials asked the TPAC board to remove providers from its board of directors because of controversies which had arisen over conflicts of interest among board members. At the time, board members representing provider agencies routinely participated in decisions which resulted in financial aid for their organizations. The inability of TPAC to address that issue led city health officials to remove over $10 million of federal AIDS funding from the group's purview, although state officials maintained their relationship with TPAC for the distribution of state AIDS education funding and federal Ryan White CARE Act funding awarded under Title II.
Last year, TPAC removed all of its previous board members and re-constituted the planning coalition, assuring that at least half of the board members were consumers and assigning responsibility for determining funding allocations to an independent group.
At an early June meeting of the TPAC executive committee, however, the group reviewed a report from the federal Health Resources and Services Administration (HRSA), which oversees Ryan White funding, which discusses conflicts of interest in Title II planning coalitions. According to this report, issued in July, 1996, TPAC's current structure is consistent with federal guidelines on managing conflicts of interest. The report also notes that states should give planning coalitions "maximum independence in developing service delivery planning, administration, and allocations processes, as opposed to outlining specific processes for them to follow."
The executive committee was also concerned that TPAC staff had not advised the board of directors of the state's new concerns about conflicts of interest until last month, even though state officials had been meeting with staff for some months on the issue. The committee also was concerned that a timeline for the board re-structuring, which called for some activities to begin in early June, had still not been implemented by the staff and that it could not be achieved by the September deadline set by the state.
The committee agreed to contact state officials to discuss these issues prior to proceeding with the re-organization.
SF AIDS Ride embroiled in controversy
by Jay Bonasi
Bay City Newswire
Increasing concern about the operation of the for-profit AIDS Ride fundraisers has reached the site of the original AIDS Ride in California, as activists have blasted the disbursement of proceeds from the upcoming "California AIDS Ride 4" in which 2,600 bicyclists will depart from San Francisco for Los Angeles on June 1.
Critics say that some 40 percent in overhead and promotional costs means that not enough money goes to support AIDS services and disease research through the San Francisco AIDS Foundation.
Philadelphia's AIDS Ride in 1996 resulted in only 19% of the proceeds going to AIDS service organizations.
However, AIDS Foundation spokesman Jeff DeLucio-Brock called the ride an annual success that has raised "very important unrestricted funds" for AIDS programs such as education, publications and outreach.
Lance Henderson, deputy director of finance and administration for the foundation, said the 1996 ride grossed $4.1 million in San Francisco pledges, of which 61.3 percent -- about $2.5 million -- was income returned to the foundation. Henderson said such a ride entails high fixed costs because essentially it involves "moving a small city down the coast."
Mike Salinas, editor of the Bay Area Reporter, San Francisco's gay and lesbian newspaper, said the ride is "not about helping the fight against AIDS enough and there are better, more cost effective ways to raise funds."
"We're talking about approximately $2 million being spent on 3,000 people in six days," Salinas said. "You can take 3,000 people to Paris for six days for that cost." Salinas is also upset about the legal ownership of the ride's name by Pallotta TeamWorks, a Los Angeles-based promotions firm founded by President Dan Pallotta.
"There's something morally questionable about copyrighting a service trademark for fighting a disease that has caused me to bury half of my friends," Salinas said.
Jeff Getty, a treatment activist for ACT UP/Golden Gate, alleges corruption in the competitive bidding process for the ride. Getty said vendor Gary Lanier made an $11,000 bid for services in last year's ride but was rejected by Pallotta for a vendor whose bid cost $5,000 more. Getty, the recipient of an experimental baboon bone marrow transplant, said he is discouraged by the lack of funding from the bike ride for AIDS research and treatment drugs for victims.
Getty said ACT UP members are "furious" with the San Francisco AIDS Foundation because too much money goes to pay salaries and "ineffective" bureaucracies. "A lot riders are misled that they are contributing to a cure," Getty said. "The promotion doesn't say 'ride to pay the salary of AIDS employees' or 'ride to pay the exorbitant profits of AIDS promoters'."
Michael Petrelis, a self-proclaimed "AIDS watchdog," also has questioned specific details about the fundraiser. In a May 22 letter to the San Francisco AIDS Foundation, Petrelis asked, "What financial and profit margin arrangements have you agreed to with the Pallotta agency?" and "What is Dan Pallotta's ... salary and compensation package?" Pallotta could not be reached for comment, and last year refused to provide that information to fastfax and other AIDS activists when the Ride occurred in Philadelphia.
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