published by We The People Living with AIDS/HIV of the Delaware Valley, Inc.
Congress acts on AIDS housing and care funding
GOP pulls back from FDA "reform" efforts
States facing squeeze on AIDS drugs
MD Medicaid cuts increases dental emergencies
Britons wary of protease drugs, expert says
Vertex/Glaxo protease set for clinical trials
Pending budget legislation funds HOPWA for the next fiscal year at $171 million -- the same level as last year and $18 million less than the year before. Because additional communities will qualify for HOPWA funding next year, the level funding will result in a reduction in funding for cities such as Philadelphia, which have been awarded HOPWA allocations for several years.
According to the AIDS Action Council, informal conference negotiations have already begun, although conferees are not expected to meet formally until next week. By that time, however, they will have a completed conference report that can quickly be agreed to and sent to the floors of the House and Senate for final passage.
To date, the attempts of AIDS advocates to get conferees to agree to a $25 million increase for HOPWA requested by the President -- required in order to guarantee no cutbacks in current levels of HOPWA services -- have been frustrated by the Administration itself, which has been, according to the AIDS Action Council, "unconscionably slow" in coming up with offsets for the HOPWA increase.
Without any offsets on the table, the Council said in a statement, it has been virtually impossible to have serious discussions or negotiations about including the $25 million increase in the conference report.
Finally this week, however, as a result of intense pressure from the community and some officials at the Office of Management and Budget and the Dept. Of Housing and Urban Development, the Administration finally identified real offsets. Serious conference negotiations to ensure the FY '97 VA/HUD conference report includes the full $196 million for HOPWA can now begin, the group said.
No Philadelphia area representatives serve on the VA/HUD conference committee. All members of the House can be reached through the Capitol Switchboard at 202-225-3121, and all Senators can be reached at 202-224-3121.
Senate committee acts on AIDS bills
Meanwhile, the Senate Labor/HHS Appropriations Subcommittee voted on its FY '97 bill this week, funding AIDS programs as follows:
**a $10 million increase over FY '96 levels for Title I of the Ryan White CARE Act; $7 million increase for Title II, not including the AIDS Drug Assistance Program (ADAP; $5 million increase each for Titles IIIb and IV of the Ryan White Act; a $4.3 million increase for the AIDS Education & Training Centers; and a $0.6 million increase for the Dental Reimbursement Program under Title V -- the same increases these programs received in the House bill;
**the $65 million increase over the specific FY '96 level for the AIDS Drug Assistance Program (in Title II of the Ryan White CARE Act) requested by the President -- $42 million more than the increase proposed by the House;
** a consolidated appropriation for the NIH Office of AIDS Research that provides an increase of $52.5 million over FY '96 levels for AIDS research. The House did not provide a consolidated AIDS research appropriation through the OAR. However, the House bill provides more money for NIH overall, and would make $39 million more available for AIDS research than the Senate subcommittee did.
** a $5 million increase for CDC HIV prevention programs--$10 million less than the increase provided by the House.
The full Senate Appropriations committee was scheduled to vote on the bill as this issue of fastfax went to press, but no changes are expected in AIDS program funding levels.
The Senate bill is not likely to go to the Senate floor, however, because there are so many contentious issues in the bill that it could get mired in endless debate. Given that FY 1996 funding expires on September 30th House, Senate and Administration negotiators will instead start crafting a year-long continuing resolution (CR) that funds the programs through the end of FY '97.
The AIDS Action Council said that it will be seeking the following guarantees in the debate on the Continuing Resolution:
**increasing funding for HIV prevention programs to the President's requested level of $616.5m ($32.5m over FY '96);
**preserving the consolidated appropriation for the Office of AIDS Research at NIH;
**increasing funding for the 4 titles of the Ryan White CARE Act to at least the President's request ($69.1m over FY '96); and
**obtaining the $190 million for ADAP necessary to prevent programs across the nation from having to shut down mid-year ($138m over FY '96).
GOP pulls back from FDA "reform" efforts
A Republican source in the House has told the newspaper Congress Daily that FDA reform failed because of a "growing reluctance" by the Clinton administration and House Democrats to negotiate an agreement with the GOP.
House Commerce Committee aides had been negotiating the reforms with Health and Human Services officials since July. However, according to the GOP source, "a chill in the air" became apparent "in the period heading up to the Democratic National Convention." The FDA reform legislation called for partially privatizing the approval process for medical devices and drugs. However, Rep. James Greenwood (R-PA) announced last week that "the issue is dead this year."
According to Congress Daily, "other sources disputed the assertion that the administration and Democrats were reluctant to reach agreement." One source said that "the Democrats are willing to talk," but have not been contacted by Republicans. Another source said that the administration does not have any say as to "whether the two sides will meet." The source added that Republicans have "declined" to hold any new meetings on FDA reform since Congress returned from its August recess. The source said that "the talks had been making progress, but Commerce Committee GOP staff refused to sign off on issues that had been resolved until negotiators worked out a final agreement." However, the two sides "remained far apart on 'big-ticket' items." Another House source said that a bill remains a possibility, "but it would have to come from the Senate."
A spokesperson for Senate Labor and Human Resources Committee Chair Nancy Kassebaum (KS) said that the senator is still trying "to get a time agreement for floor consideration of FDA reform legislation approved by her committee. However, Sen. Edward Kennedy (D-MA), the ranking member of the committee, has expressed his opposition to the measure. A Kennedy spokesperson "said the tight FY '97 appropriations schedule may rule out floor consideration of FDA legislation." The House GOP source said that even without a bill, the move to reform the FDA "has been a partial success because the political attention forced the agency to make internal reforms and speed up the approval process." In addition, the source said that "with so much progress, House Republicans may be able to pass a stripped-down version of the bill."
States facing squeeze on AIDS drugs
Caught between the promise of new AIDS drugs and their rising cost, many U.S. states are limiting access to life-prolonging therapies.
A survey released this month found that about half the 50 states were introducing or contemplating such restrictions as waiting lists, lotteries and even the temporarily barring of new patients from AIDS Drug Assistance Programs (ADAP).
Part of a federal AIDS initiative known as the Ryan White Act, ADAP fills the financial gap for patients who are too poor to spend thousands of dollars a year on AIDS drugs but not poor enough for Medicaid health coverage. ADAP funds access to AIDS medications in New Jersey and Delaware. Pennsylvania's Special Pharmaceuticals Benefits Program is not supported with ADAP funds.
The survey prompted patients, doctors and AIDS activists to call for another infusion of federal funds to make sure everybody who needs the drugs gets them. A $52 million boost in federal funding earlier this year will not be enough for many states to make it through the year.
"If we don't have access, we don't have hope. You might as well say, 'Lay down and die,"' Kim Williams, an HIV-infected woman from Mississippi, said. "A lot of people are not ready to die. I'm 25. I'm not ready."
She appeared at a news briefing sponsored by members of Congress and by a coalition of AIDS activist groups and drug companies seeking $200 million more in federal AIDS drug assistance and $70 million more in state assistance next year than was made available in 1996.
The survey, by the National Alliance of State and Territorial AIDS Directors, found cost increases in state ADAP of up to 427 percent in the first seven months of the year because of both the price of drugs and the flood of new patients who can benefit from them.
Unlike earlier medicines, which had limited effectiveness and were recommended only for those with full-blown AIDS, "cocktail" combinations of new drugs appear to control -- though not cure -- HIV in people in the earliest stages of infection. But that means a far bigger pool of potential patients.
The cocktail of older antiviral drugs plus a new class of medicines called protease inhibitors is expensive, costing about $10,000 to $13,000 per year per patient, according to the most recent estimates.
"Our cost went from a projected $1.1 million this year to a projected $6.1 million -- a 500 percent increase," Washington state Gov. Mike Lowry said. He briefly shut the ADAP program this summer and then reopened it despite the $5 million shortfall in a $44 million state health budget.
"We cannot close this program. It is saving people's lives. It is saving young people's lives," he said, urging the federal government and the drug companies to help.
Because of costs, at least 22 state ADAP programs are limiting or expect to limit access. Fourteen states have not yet begun offering protease inhibitors through ADAP. Some, like Florida, indicated in the survey that they did not foresee having the money to offer wide-reaching drug assistance.
"For the first time in a long time, I've thought about the future," Paul Moore, a 30-year-old, HIV-infected man from Portland, Oregon, told the briefing. "Please support this. Please fund this. It's so needed."
MD Medicaid cuts increases dental emergencies
After dental benefits were cut from adult Medicaid benefits in 1993, Maryland's dental benefits have become "among the worst in the nation," According to the Baltimore Sun. Researchers link the cut in benefits to a 21.8% increase in emergency room visits for Medicaid beneficiaries in dental crises.
A recent University of Maryland Dental School study shows that overall emergency room visits by Medicaid beneficiaries decreased overall during the same time period. The Sun reports that adults presenting dental crises in the emergency room can only receive "painkillers and antibiotics" and the root of the problem cannot be fixed because basic dental services are not covered. Steven Ashman, director of oral and maxillofacial surgery at Johns Hopkins Hospital, said, "They take up the health care system at its most expensive end."
A new study revealed that over half of the cavities in the state's children are not treated. Rural residents have unfluorigated water, which results in a high percentage of cavities. Maryland ranks 27th in a nationwide study of people with oral cancer, but due to low screening and diagnosis rates, Maryland ranks fourth in deaths from oral cancer.
A 1995 survey by the American Dental Association found that eight other states offer no dental benefits for adults. In Maryland, even children with benefits often don't receive treatment because dentists say "they are paid about 20 percent of what it costs to provide care" and refuse to service Medicaid beneficiaries. The inspector general's office of the U.S. Health and Human Services Department is now investigating "whether Maryland is violating federal law because its low payments to dentists discourage them from seeing the children." Advocacy groups have already forced three other states to boost their payments to dentists through court action. About 250,000 of Maryland's Medicaid recipients are scheduled to be moved in January into managed care plans that provide for children's dental care. State Dental Director Dr. Harry Goodman said "one of his primary goals will be to monitor plans to ensure that children do get the care." He said, "I need, as one voice up there, to represent dentistry." Dr. Martin Wasserman, state health secretary, said that there has been "a definite lack of interest" in dental benefits in the past. He added, "I hope that for limited amounts of money, we'll be permitted to expand these services next year."
Britons wary of protease drugs, expert says
British doctors are more wary than their American counterparts of the new protease inhibitors will use them more cautiously, an expert said this month.
Dr. Ian Weller of University College London said the long-term effects of protease inhibitors were not known and he would be conservative about prescribing them.
Protease inhibitors are a new class of drugs that are believed to stop HIV at one point in its replicative cycle. Other drugs, such as the commonly-used AZT, hit the virus at a different stage.
Drugs such as 3TC often prescribed in combination with AZT target yet another stage. Researchers have reported remarkable results with combination or cocktail therapy, with some studies showing marked increases in how long AIDS victims live.
Triple therapy, using the protease inhibitors, shows even stronger results and researchers at the Aaron Diamond AIDS Research Center in New York said they had obliterated all traces of the virus from volunteers.
This finding caused some scientists to whisper the word "cure" at the International Conference on AIDS in Vancouver last July.
But Weller says this is premature.
"You are actually committing people to many, many years of treatment with combination drugs and you don't know what the long-term effects are," he told a news conference.
"The danger in starting early ... is that you will run out of drugs later, when you really need them."
Aaron Diamond researchers have advocated doses of three different types of drugs early on in HIV infection, to hit the virus early and hard while the sufferer's immune system is strongest.
Weller also disputed their findings that the virus had been knocked back to low or undetectable levels. Scientists did not know where the virus might reside in the body, he said.
"The virus could be sitting in another compartment we are not looking in, actually smiling," he said.
Doctors know HIV infects immune system cells known as CD4 cells and some studies indicate it resides in the lymph glands as well as in blood serum. Last week British researchers reported they had also found HIV in another class of immune cells, the CD8 cells, which scientists had thought were immune from infection.
Several protease inhibitors are licensed in the United States but European regulators have just approved the first one, Abbott Laboratories Inc.'s Norvir, for use in Europe. AIDS groups praised the move and called for more drugs to be made available.
Vertex/Glaxo protease set for clinical trials
The AIDS Clinical Trials Group (ACTG), a cooperative group supported by the National Institute of Allergy and Infectious Diseases, will conduct a 24-week Phase II monotherapy study of 141W94/VX-478, an HIV protease inhibitor being developed by Vertex Pharmaceuticals, Glaxo Wellcome, and Kissei Pharmaceutical Co.
The HIV Disease Research Agenda Committee of the adult ACTG has approved the trial, which is designated protocol 347. As the largest HIV clinical organization in the world, the ACTG plays a major role in setting standards of care for HIV infection and opportunistic diseases related to HIV/AIDS in the United States and the developed world. Vertex discovered 141W94/VX-478 and is developing the drug with Kissei, in the Far East and with Glaxo Wellcome, worldwide outside of the Far East.
In a Phase I/II international clinical study sponsored by Glaxo Wellcome, 141W94/VX-478 was well-tolerated and displayed potent antiviral activity as a single agent. Preliminary results from this dose-escalating, 28-day trial will be presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) meeting in New Orleans, next week.
The ACTG study has been designed to better understand the activity and potential of 141W94/VX-478 as a single agent. The focus of Glaxo Wellcome's ongoing development of this drug is in combination with other antiretroviral drugs. The ACTG study will complement a wide array of studies, underway or planned, testing 141W94/VX-478 in combination with antiviral drugs such as Glaxo Wellcome's Retrovir (AZT) and Epivir (3TC). In the United States and Europe, Glaxo Wellcome is conducting several clinical trials aimed at testing 141W94/VX-478 in combination with antiviral agents, including a 12- week dose-range finding study of 141W94/VX-478 in combination with Retrovir (AZT) and Epivir (3TC). Kissei has completed Phase I studies in Japan, and plans to undertake efficacy studies in 1997.
The ACTG Phase II trial, which is expected to start in the fourth quarter, is a 24-week double-blind, placebo-controlled clinical study designed to test the antiviral efficacy, tolerableness and pharmacokinetics of two doses of 141W94/VX-478 (900 mg or 1200 mg twice daily) versus the combination regimen of 141W94/VX-478 (900 mg twice daily) plus Retrovir (AZT) and Epivir (3TC). The study is expected to enroll approximately 126 HIV-positive individuals. The study provides for patients not responding adequately in the monotherapy arm of the study to be switched to combination treatment, if necessary. In a subset of volunteers, the study will assess the penetration of 141W94/VX-478 into cerebrospinal fluid.