PI Action alerts & updates ... 1997

Balanced-Budget Agreement
Includes Cuts in Health Spending

After a long process, Congress and the Clinton Administration recently reached an agreement on the balanced-budget package. The plan reduces overall discretionary spending for health programs by 16% and cuts federal tax revenue by $91 billion over the next five years. As reported in last month’s update, HIV/AIDS and other health programs were de-prioritized as part of the overall agreement.

In addition, Medicaid spending will be cut by $13.6 billion over the next five years and Medicare by $115 billion. While Medicaid cuts are far less than the $182 billion proposed by Congress two years ago, they will still have an impact on health care and treatment access for people living with HIV/AIDS and other life-threatening illnesses. In particular, the majority of the cuts will be in payments to “disproportionate share” hospitals (DSH). DSH payments go to hospitals that serve a relatively large number of indigent and Medicaid patients.

Fortunately, the proposal does not include a major overhaul of Medicaid, such as block grants or elimination of AIDS in the definition of disability. However, the final agreement does contain some provisions of concern to people living with HIV and AIDS, including giving states the authority, without going through a waiver process, to mandate that Medicaid beneficiaries enroll in managed care plans. Some consumer protections that will apply to all Medicaid managed care plans were approved; however, they are not as broad as consumer advocates would like.

The details of this provision could be significant, given the problems people living with HIV/AIDS have experienced with Medicaid managed care, in spite of federal oversight. We will report in more depth in an upcoming TAN mailing.

Broad Support Growing for Needle Exchange Programs
In July, the U.S. Conference of Mayors and the American Medical Association approved resolutions calling for the removal of the federal ban on funds for needle exchange programs. The American Bar Association voted in favor of a similar resolution last week.

Current law states that no federal funds may be used for needle exchange programs unless the Secretary of Health and Human Services certifies that the programs reduce HIV transmission and do not increase drug use. Several studies, including those commissioned by the federal government, have demonstrated that these requirements have been met, yet HHS Secretary Donna Shalala has not made this declaration.

Needle exchange advocates are organizing a grassroots campaign to overturn this ban. You are encouraged to contact the White House at 202-456-1111 or president@whitehouse.gov with the following message:

“I urge the Clinton Administration to end the federal ban on needle exchange programs. Numerous studies have determined that these programs reduce HIV transmission and do not increase drug use. Local communities should be able to determine their need for needle exchange programs.”

Glaxo Wellcome Begins Compassionate Use Program for 1592
In July, Glaxo Wellcome began its compassionate use program for 1592. The program will provide the treatment to 2,400 individuals in the United States and is expected to expand in early 1998, depending on increase in production.

Currently, qualified individuals must have a CD4 count less than 100 and a viral load over 30,000 copies of HIV RNA. In addition, participants must be intolerant to one nucleoside and one protease inhibitor or have failed combination therapy with two nucleosides and one protease inhibitor. If you are interested in participating in this program, you can have your doctor call 800-501-4672.

However, before rushing to use this drug, Project Inform has identified a few points to consider, including:

• New clinical trial data suggests that 1592 is less likely to be effective in people who have previously used an AZT/3TC combination or ddI. There is clearly some level of cross-resistance between 3TC, ddI, and 1592.
• Simply adding 1592 to a failing treatment regimen is not likely to help much. For many, it will be wiser to wait until it is possible to start two new, previously unused drugs at the same time. Another new drug, DMP-266 from Dupont-Merck, is expected to go into some form of expanded access in late 1997, while at least two others will begin to be widely distributed in 1998. For most people, it is more important to use a new drug wisely than simply to use it now.

Glaxo has also recently implemented a 1592 expanded access program for children. If you want more information about that program, or 1592 in general, please contact Project Inform’s National HIV Treatment Hotline at 800-822-7422.

Treatment Advocates Express Outrage over Glaxo Clinical Trials
At a recent meeting of the Antiviral Drugs Advisory Committee of the FDA, treatment advocates condemned Glaxo Wellcome’s clinical trials for its new drugs 1592 and 141. Both of the studies are designed to compare AZT + 3TC + 1592 (or 141) to AZT + 3TC. This means that some trial participants would receive only AZT and 3TC as antiviral medication. Based on data presented at the meeting, and the new federal guidelines on HIV care, AZT + 3TC alone is no longer considered a viable treatment regimen.

Advocates are calling on the FDA to refuse to accept data indicating superiority to an inadequate combination as the basis for the approval of 1592 and 141, and are asking researchers to consider the ethics of agreeing to conduct the studies at their facilities as data now clearly shows the inferiority of the AZT + 3TC regimen compared to triple-drug regimens. In addition, people should think twice about participating in a study that could subject them to sub-standard treatment. If there is such a trial in your area, you are encouraged to contact the researcher and convey your concerns.

Unfortunately, should this pressure result in changing the study designs, it will extend the time needed to complete acceptable trials of the drugs. The result will likely be a delay in the approval and availability of these treatments.

Federal Guidelines on HIV Care Available to Public
You can obtain a copy of the Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents from the National AIDS Clearinghouse 800-458-5231 or www.cdcnac.org) or the HIV/AIDS Treatment Information Service 800-448-0440 or www.hivatis.org).