Presidential Advisory Council on HIV/AIDS
Second Progress Report
December 7, 1997
In the 5 years since he assumed office, President Clinton has dramatically improved the national response to AIDS. Since 1993, funding for the Ryan White CARE Act has increased by 200 percent, spending on AIDS research has grown by 50 percent, HIV prevention funding has increased by 27 percent, and federal support for the Housing Opportunities for People With AIDS (HOPWA) program has grown by 104 percent. Approval of new drug therapies has been expedited. Due in large measure to the Office of AIDS Research (OAR), which was proposed by the Clinton Administration, AIDS research funds are spent more efficiently and strategically. As a result of improvements in the medical management of HIV disease, the nation has witnessed the first ever decline in the annual number of AIDS deaths. In addition, the President's AIDS vaccine initiative has placed a long-overdue spotlight on the world's reliance on the U.S. for the development of a safe, effective vaccine. As history will undoubtedly record, President Clinton is the first American chief executive to take serious action to address the AIDS crisis. However, most of these important strides occurred during the President's first term.
Despite substantial and diligent efforts on the part of Office of National AIDS Policy (ONAP) Director Sandra Thurman, the ONAP staff, and the Executive Director of the Presidential Advisory Council on HIV/AIDS (PACHA), progress in the federal response to AIDS has stalled in recent months, contributing to a sense of diminished priority for AIDS issues during the President's second term. We are concerned that ONAP has not been provided with adequate staff or appropriate status within the White House structure needed to make it most effective. When the future of funding for the AIDS Drug Assistance Program (ADAP) was at risk earlier this year, AIDS advocates were forced to look to Congress, not the White House, for leadership. In May, the Vice President announced a 30-day expedited Administration review of the feasibility of expanding Medicaid to cover all indigent HIV-infected individuals; however, many months have passed, no pilot project has been put in place, and the Administration continues to send mixed and conflicting signals regarding its pursuit of the objective of expanding Medicaid coverage. The combination of these actions raises serious questions about the current priority of AIDS issues for the Administration.
In one crucial area of the federal response to AIDS -- the national effort to prevent HIV transmission -- the Administration, like its predecessors, has failed to lay out a coherent strategic plan of action. Funding for HIV prevention remains inadequate, particularly when compared with the monumental bill for medical expenses and lost productivity stemming from HIV disease. With respect to the sparse funding that does flow each year to State and local health departments to support HIV prevention activities, the Centers for Disease Control and Prevention (CDC) has incorporated community planning as a primary implementation strategy but has not fulfilled its oversight responsibility to ensure that States and localities effectively target the limited dollars available. Despite the scientifically verifiable evidence that has long existed regarding the efficacy of needle exchange programs, Secretary of Health and Human Services (HHS) Donna Shalala has yet to make the public health determination legally necessary to allow local communities to use federal funds to support this life-saving intervention. On this issue and others listed below, the Administration has sometimes failed to exhibit the courage and political will needed to pursue public health strategies that are politically difficult but that have been shown to save lives.
Recent medical developments have injected a spirit of hope in the battle against the disease. Hope, however, is fragile, and apathy is its enemy. Far too many Americans lack access to effective medications, and far too many patients are failing on the new drugs. Due to gaps in access to basic health care and social services, which make it difficult for many people with HIV to comply with demanding treatment regimens, the nation also faces the alarming risk of widespread HIV drug resistance. Tens of thousands of Americans -- as many as one-half of them teenagers or young adults -- become infected with HIV each year. Globally, new evidence indicates that the number of people infected with the virus is far larger than originally believed, and growing rapidly, underscoring the overwhelming need to develop a vaccine capable of bringing the worldwide epidemic under control.
Unfortunately, large segments of some populations affected by the epidemic do not have access to recent therapeutic advances. HIV infection continues to increase among women and other people of color. Blacks and Latinos continue to be disproportionately affected by the virus. On average, people with HIV infection in the U.S. are poorer in 1997 than they were 10 years ago. And, as the new therapies extend life for many people with HIV, the HIV-infected population grows, placing even greater burdens on already strapped systems of care.
With major challenges still ahead, and countless lives in the balance, now is not the time for complacency. History will judge this society by the choices we make. As a nation, we may either demonstrate the conviction and endurance needed to bring the epidemic to an end, or allow apathy and weariness to sow the seeds of even greater future loss of life. The right choice requires bold and courageous leadership. In order to take advantage of the solid achievements of this Administration during its first term and to tackle still daunting issues regarding HIV/AIDS that remain, a renewed dedication to action is essential.
More than 16 years after the epidemic was first recognized, the United States still has not laid out a coherent, effective national strategy to prevent HIV transmission. Experts estimate that more than 40,000 Americans will have become infected with HIV this year alone. Despite a wealth of knowledge regarding the elements of an effective HIV prevention strategy, there is little evidence that the nation has made significant progress in reducing the number of new HIV infections in recent years.
During the early years of the epidemic, former Surgeon General C. Everett Koop and eminent organizations such as the Institutes of Medicine and previous Presidential Commissions recommended that the country adequately invest in programs to provide frank, explicit, culturally relevant HIV prevention information to those at risk for sexual transmission. Similarly, leading experts have long recommended that the nation's leaders ensure the availability of drug treatment on demand and address counterproductive drug paraphernalia laws. Yet, many years later, our national prevention effort ignores these sound recommendations.
Studies of the populations most heavily affected by the epidemic have repeatedly demonstrated that prevention initiatives lead to substantial changes in self-reported sexual behavior. This research indicates that prevention programs that address sexual behavior are most effective when they provide explicit information in clear, culturally sensitive language, are ongoing, assist individuals in developing sexual negotiation skills, and are administered by members of the target population.
Perhaps most disturbing is the continued prohibition on federal funding for needle exchange programs despite clear scientific evidence of the efficacy of such programs in preventing new HIV infections without increasing substance use. At least 50 percent of new HIV infections are traceable to injection drug use. The HHS Secretary has for some time had the legal authority to lift funding restrictions, yet she has failed to do so. The Council applauds the Administration's successful effort earlier this year to preserve the Secretary's authority to waive funding restrictions. However, the Administration has thus far expended little effort to educate Congress and the American public about the effectiveness of needle exchange programs or to build political support for such programs. The Administration should demonstrate leadership on this issue by immediately certifying the public health utility of this life-saving intervention as a component of a continuum of effective HIV prevention services for injection drug users.
Although powerful evidence of the effectiveness of HIV prevention demands a robust and energetic response, the Administration has failed to provide such bold leadership. The federal investment in HIV prevention is disproportionately small compared to the amount of the epidemic's annual price tag in medical care and lost productivity, let alone in human suffering and loss of life.
Moreover, the Administration often fails to make optimum use of its limited investment in HIV prevention. It has maintained outdated restrictions on the ability of some federally funded HIV prevention programs, especially those targeting school-aged youth, to provide explicit and appropriate information to those at greatest risk. As a result, many HIV prevention educators must censor themselves with an eye to retaining their funding rather than providing the most effective prevention message possible.
At least 25 percent of all new infections occur among individuals under the age of 22. While the CDC is taking steps to improve and expand its efforts to target youth at high risk for HIV infection, including gay youth and young women of color, the agency's efforts to educate youth regarding HIV remain uncoordinated and unevaluated. On World AIDS Day, the President issued a directive to all federal agencies to identify all programs serving young people that offer significant opportunity for preventing HIV infection and to develop a specific plan to use those programs to increase access to HIV prevention and education information, as well as to supportive services and care for those already infected. This process provides a significant opportunity to assess, coordinate, and expand federal efforts to prevent HIV transmission among America's young people.
We are encouraged by the leadership of Dr. Helene Gayle at the CDC and are impressed by the senior team she has assembled. In particular, we appreciate both Dr. Gayle's involvement of affected communities in the development of HIV prevention strategies and the CDC's continued support of HIV prevention community planning. Unfortunately, the CDC inadequately monitors the public health uses to which federal HIV prevention funds are put by State and local health departments. Consequently, we are concerned whether limited prevention dollars target those at greatest risk. We strongly encourage the CDC to continue its recently strengthened efforts to track the expenditures of its grantees' prevention programs and to ensure that these expenditures address the needs of persons at greatest risk. We look forward to a report at our March meeting on recent expenditures analysis.
In 1996, President Clinton challenged the nation to reduce the number of new HIV infections each year until there were none. Sadly, no coherent plan exists for achieving this noble objective. In the absence of bold leadership and aggressive action on the part of the Administration, the nation stands little chance of substantially reducing the number of new infections.
The President is to be highly commended for his leadership efforts to expedite the work of developing an AIDS vaccine. The President's announcement in May, 1997 of the goal of developing an AIDS vaccine within a decade, and the focus of attention on an AIDS vaccine during the Denver Summit meeting are greatly appreciated and acknowledged worldwide. But much more must be accomplished. Remaining to be addressed are the Council's prior recommendations for: (1) a significant and sustained increase in additional and new funding for AIDS vaccine development; (2) coordinated and comprehensive involvement by all relevant federal agencies in the effort; (3) close federal collaboration with the private sector, international community, and independent vaccine initiative; and (4) the convening of a public-private AIDS consultative forum.
We would like to commend the Food and Drug Administration (FDA) for its efforts in addressing some of the issues we raised concerning women and children infected with or affected by HIV/AIDS. The FDA has published proposed guidelines on expectations regarding inclusion of patients of both genders in drug development, analyses of clinical data by gender, assessment of potential pharmacokinetic differences by gender, and conduct of specific additional studies in women, where indicated. The Council reaffirms our previous recommendations and supports the FDA's proposed guidelines. We appreciate the FDA's efforts in seeing that the labeling process of marketed prescription drugs includes the accumulation and dissemination of pediatric data; however, we are still awaiting our requested review of the number of children actually enrolled in NIH-sponsored clinical trials.
Although it has not been enacted by Congress, the President and Vice President have continued to support the recommendation for a coordinated federal approach for HIV/AIDS research through support for the OAR, including staunch advocacy for a consolidated budget for AIDS research at the NIH.
Some progress on microbicide research has been achieved, and Secretary Shalala announced in July, 1996 that $100 million would be spent on microbicide research over the next 4 years. However, no new Federal full-time equivalents (FTEs) have been designated to this effort, no new Requests for Applications (RFAs) have been issued that might stimulate the interest of new investigators in the field, and there has been no response to our recommendation that a public health consensus panel be convened to assess the efficacy of available spermicides and other licensed products. Further, the Council has not received a detailed accounting of the monies expended for microbicide research, and we are concerned that no new monies have been designated specifically for this purpose.
Our recommendation to create mechanisms for the rapid translation of breakthrough findings into clinical practice has been partially addressed by the NIH in the area of biomedical research. Several approaches now exist; however, in the area of behavioral and social science, creative mechanisms that facilitate rapid translation of these research findings still need to be developed.
HIV/AIDS requires extensive medical care. Access to such care upon diagnosis is essential and can often result in greatly extending both length and quality of life for those infected. HIV/AIDS medical care also is expensive and, therefore, for those without adequate health insurance or significant personal resources, often unavailable. The Administration's proposal for universal health insurance would have ensured such care for most HIV-infected Americans. Unfortunately, Congress rejected that proposal. As a result, we are left with a piecemeal system of health care in which many do not have access to basic primary medical care or the promising new combination drug therapies, which offer them the best chance for long-term survival. Medicaid, upon which more than 50 percent of people with AIDS rely for health care, and the Ryan White CARE Act are the existing programs through which most HIV/AIDS care is currently provided.
Since July, 1996, the Council has urged the Administration to begin reviewing existing programs and developing new approaches for providing primary medical care and access to the new drug therapies. In December, 1996, PACHA formally recommended that HHS develop new policies and provide requisite funding to ensure availability of these therapies to all those who need and cannot otherwise afford them, in accordance with HHS recommended treatment guidelines. In particular, we focused on the following actions:
This past spring, Vice President Gore called for HHS to explore and report to him within 30 days on the feasibility of expanding Medicaid coverage to cover early-intervention HIV therapies. Accordingly, many dedicated public servants within HHS are working diligently to find a means of expanding Medicaid eligibility, and we commend their efforts. We are particularly encouraged that the Health Care Financing Administration (HCFA) has been working closely with the AIDS community and outside policy experts to attempt to develop a viable, cost-effective, ethically appropriate mechanism to provide such expansion. However, we have been deeply disappointed by the apparent absence of personal leadership on this issue from Secretary Shalala and by the mixed and conflicting messages from the Administration of its true intentions regarding this initiative. In a recent meeting attended by Council members, the Secretary suggested the alternative possibility of proposing increased support for ADAP. That option engenders skepticism since it was Congress, rather than the Administration, that proposed increased ADAP spending in the 1998 federal budget.
The Council has formally recommended that mandatory HIV testing by and/or discriminatory policies of the U.S. Foreign Service, the Peace Corps, the Job Corps, the State Department, and the military be rescinded unless justified by a compelling public health rationale. During its meeting with the President 2* years ago, the Council raised this issue and the President responded in a supportive manner.
Since then, the Job Corps has revised its policy from requiring special mandatory testing to routine testing for HIV as part of its entry process. It retains more than 80 percent of those who test HIV-positive and provides requisite counseling and referral to medical care, regardless of whether HIV-positive applicants are subsequently accepted as students. This exemplary policy by the Job Corps should be commended.
The Department of Defense (DOD) maintains stringent standards for appointment, enlistment, or induction into military service. The DOD does not discharge individuals testing HIV-positive after appointment, enlistment, or induction solely on the basis of a positive test. Periodic medical evaluation of fitness for continued service of HIV-positive personnel is conducted in the same manner as for personnel with other progressive illnesses. Evidence of HIV infection may not be used as a basis for any disciplinary action and HIV-positive personnel are assigned within the U.S. in order to ensure access to appropriate medical care. The DOD policies regarding HIV-infected individuals appear to be comparable to those for other medical disqualifications. Its policies regarding those subsequently infected are exemplary and should be commended.
The U.S. Foreign Service requires mandatory HIV testing, and those found to be HIV-positive are disqualified from entry (subject to a possible waiver, which is seldom granted) because of the resulting limitations on "worldwide availability" for placement. Foreign Service employees who become HIV-positive subsequent to entry are issued limited medical clearances and may serve in countries where adequate medical care is available. While treatment of subsequently HIV-infected individuals appears to be comparable to treatment of those with similarly serious medical conditions, more information is needed to clearly demonstrate equitable treatment. For those disqualified from entry, more data is needed to show the practical application of the worldwide availability for placement criteria and if HIV-infected applicants are, in fact, treated comparably to those with similarly serious medical conditions.
The Peace Corps requires HIV testing as part of a comprehensive pre-entry medical assessment. HIV is listed as a condition that, with rare exception, the Peace Corps is unwilling to reasonably accommodate. It further provides for deferred entry with certain conditions after a specific time period. Advances in HIV therapy and resulting improvements in general health and quality of life for HIV-infected individuals may require future recategorization.
After much debate and discussion, the CDC finally has scheduled a working group meeting of external experts for early 1998 to review CDC guidelines for preventing HIV transmission from infected health care workers. It is our sincere hope that this will lead to prompt revision of its current discredited and discriminatory guidelines.
Since 1990, HIV/AIDS has been the second leading cause of death in prisons. The incidence of AIDS in prisons is six times greater than the incidence in the general population. For many incarcerated persons, prison may be their first contact with medical and psychosocial interventions as well as their first opportunity for alcohol and drug treatment; therefore, prisons provide an ideal environment for prevention and education efforts. A prisoner's health status upon returning to society has a direct bearing on the health of the communities into which he/she returns.
Information from the Department of Justice concerning health care policy in prisons has been useful; however, the information we have received from the Federal Bureau of Prisons has been incomplete and lacking the substance necessary to assure us that the well-being of inmates in our nation's prisons is not at risk. Information from the Department of Defense concerning military prisons and brigs was also requested, but has not yet been received by the Council. A number of concerns outlined in our 1996 report have not been addressed, and many appropriate recommendations from the National Commission on AIDS have not been implemented.
Since most incarcerated individuals do not remain incarcerated forever, discharge planning for inmates with HIV/AIDS is essential. Pre-release case management and discharge planning are important in ensuring that HIV-infected inmates who have been released or paroled have access to the broad range of services needed to make a healthy and successful transition back into their communities. We continue to believe that other alternatives for compassionate release, consistent with standards such as those adopted by the American Bar Association (ABA), should be examined as an alternative to the current Federal Bureau of Prisons guidelines.
During incarceration, inmates should have access to comprehensive and current medical therapy. It is our understanding that Medical Standards of Care include all FDA-approved treatment modalities. Appropriate use of these therapies needs to be closely evaluated. Federal prisoners should also have access to compassionate-use therapies that have proven efficacious but have not been FDA-approved.
The link between HIV and substance abuse has been clearly established, yet access to essential substance-use interventions continues to be variable among institutions. Federal officials report that "inmates who volunteer for treatment are admitted into residential substance-abuse programs in sequential order based on release date." While we applaud this effort, we encourage the Federal Bureau of Prisons to evaluate waiting periods and expand programs to accommodate all inmates seeking treatment. In addition, discussions should continue on inmate access to clean substance-use paraphernalia.
Although federal officials responded to our queries on protective barriers, they remain extremely resistant to changing their current policy which states, "condoms and/or dental dams are not medically necessary for use other than during sexual activity and therefore are not authorized." We feel that this approach is shortsighted. Also, the scientific literature does not support the Bureau of Prisons' concern that access to protective barriers would "create an environment in which control would be difficult." The documented transmission of sexually transmitted diseases (STDs) in prisons underscores the fact that sexual behavior is indeed occurring; therefore, this policy should be reconsidered and successful models using protective barriers should be examined.
Despite the policies and procedures developed by the Federal Bureau of Prisons, testimony from current and former inmates reveals that these policies are not administered evenly and uniformly. The Council remains committed to a stronger investment in HIV prevention and care for incarcerated individuals. We believe that such a commitment would be significant in reducing the spread of HIV disease within all of our communities.
Recent data has confirmed our fears that the global HIV/AIDS epidemic is, in fact, worse than had been predicted. Important as the new developments in therapy are in reducing the suffering and prolonging the lives of people living with HIV/AIDS in the few countries where treatment is possible and affordable, too little is being done to halt the relentless march of this disease in Africa, Asia, Latin America, and Eastern Europe. Thus, the President's leadership in setting as a goal the development of an AIDS vaccine in the next ten years merits sincere praise.
The inclusion of HIV/AIDS on the agendas of bilateral and multilateral meetings, such as occurred at the Denver Summit, also represents a significant achievement by the Administration. The Administration also deserves credit for ensuring the prompt filling of vacancies in the United States Agency for International Development (USAID) with individuals expert in the subject of HIV/AIDS. The dialogue between USAID and nongovernmental organizations is to be commended.
The global HIV/AIDS crisis, however, constitutes a direct threat to the economic and strategic interests of the United States. In light of the ever-worsening global epidemic, PACHA is disappointed that the Department of State has not conducted an evaluation of the successes and failures of its 1995 "International Strategy on HIV/AIDS." The Strategy was developed and issued in 1995 as a 2-year plan. It must be thoroughly assessed, and a current international strategy should be developed promptly with input from domestic and international organizations involved in the response to the global pandemic.
Until a vaccine is globally available, the United States must consistently and affirmatively reestablish its commitment to lead a worldwide effort to reduce the rate of new infections. Such leadership must include the direct involvement of Secretary of State Madeleine Albright, as well as increased funding of global AIDS programs in U.S. agencies and U.S.-supported international organizations. The lofty objectives contained in the International Section of the National AIDS Strategy must be pursued and achieved in a vigorous and coordinated U.S. government effort -- before it is too late to make a difference in the social, economic, and political impacts of the pandemic.
R. Scott Hitt, M.D., Chair, Los Angeles, CA
808 17th Street, N.W.
Washington, DC 20006
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