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As we do so, however, we are increasing the demands on the health care and social service systems of our Nation.
Our budget request of $1.9 billion for AIDS reflects a continuing emphasis on the basic areas in which we have the best opportunity for long-term benefits: basic research, development and testing of new therapies and vaccines, and risk assessment, education and prevention programs. We have also requested funds to continue treatment programs authorized under the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act. Further, HCFA estimates that in FY 1992, its expenditures for AIDS treatment will increase $310 million from FY 1991, to $1.36 billion, a 30 percent increase. Also, we are requesting funds for CDC prevention programs under Title III of the CARE Act. We are concerned, however, that this authorization divides the money between traditional prevention efforts and early intervention activities for people who are infected, thus, reducing Federal monies available for counseling, testing, and partner notification programs.
Question. Dr. Mason, the Public Health Service request for AIDS is $1.950 billion: $899 million for research, up to 5.8 percent from last year; $220 million for Ryan White, $655 million short of the authorized level with no increase from last year, and $1.119 billion for information, prevention, testing and counseling programs, up 1.8 percent from 1990.
I understand that the Public Health Service request for AIDS to the Department was $2.022 billion, or $83 million more than the number we now see. And the difference was in ADAMHA and NIH research.
If additional funding were available for 1992 for AIDS, which area should be given priority for additional funding?
Answer. If additional funding were received in 1992 for AIDS the priority given would be to increase prevention activities.
Question. As you know, increases for pediatric AIDS have far outstripped the increase for non-pediatric AIDS. For example, last year the two rates were 16.9 percent as the general increase and 24 percent for pediatric AIDS.
Also, because of the priority given to pediatric AIDS clinical trial units last year, 37 percent of all clinical trial funding, will go to pediatric units while only approximately 1.5 percent of the cases are pediatric cases. Has too much priority been given to pediatric AIDS?
Answer. Basic research on pediatric AIDS should continue to be of high priority, and more research needs to be done in this area to provide information that will improve the management of HIV infected children and provide the basis for development of therapeutics and vaccines for this population.
During the last several years, the changing demographics of the epidemic and the paucity of information about therapeutics for children with AIDS has resulted in a marked increase in funding for pediatric AIDS clinical trials. As a result, AZT has been licensed for use in children and an increased number of protocols are evaluating additional drugs for use in children. However, as noted, a result of this increase has been that the funding for AIDS clinical trials for children is disproportionate to the number of cases in children. Some of this disproportionate funding is inevitable because of the demands of research; for example, a clinical trial that needs 200 patients to achieve significant results needs 200 patients regardless of whether they are adults or children. Also,
the special needs of the clinical trials for children may require per patient costs that are considerably higher than for adults. Nevertheless, the recent congressional earmark for pediatric AIDS clinical trials has further increased the level of funding for this effort and has caused the NIH concern since sufficient additional funds were rot provided and ongoing research in other areas will have to be reduced. Of particular concern is the increasing trend to divert scarce research dollars for health care needs. The NIH agrees that a certain level of ancillary services are required to ensure that pediatric populations are able to participate in clinical trials. However, these ancillary services should be commensurate with the level required to ensure that pediatric patients may participate in trials rather than providing the full range of health care coverage.
Broad based efforts are needed in vaccine and drug development, epidemiology studies, and clinical trials for all populations. We want to continue intensive efforts in all areas of basic research that will be of benefit to all affected populations, as well as to continue research targeted to understanding the disease in different affected populations as the demographics of the epidemic evolve.
Question. Late last year, the Department opted to change the Title'x funding formula, without consulting the authorizing or Appropriations Committees. I opposed the change, and was pleased that the Department agreed to leave the formula as it is.
The FY 92 budget proposes turning the family planning program into a State-run block grant. Yet I understand plans are also being drawn up to centralize the grant-making authority for Title x here in Washington. Congress has rejected both of these proposals in the past. Needless to say these proposals raise the concern that awards will be made on an ideological or political basis.
Dr. Mason, you know that old saying, "if it ain't broke, don't fix it". Why is the Department proposing to centralize the grantmaking authority for Title x in Washington?
Answer. Although no final decision has been make, we are moving toward recentralization of grant authorities and realignment of staff for the agency programs of Health Resources and Services Administration, the Centers for Disease Control and the Indian Health Service.
Title X, as an Office of the Assistant Secretary for Health (OASH) program, would continue to be managed, as it is now, with authority delegated from me to Dr. Archer, the Deputy Assistant Secretary for Population Affairs, and from him to the Regional Health Administrators.
As we have indicated previously to the Committee, we would not make any changes in Title å without consulting with Congress.
Question. In the next few months, the U.S. Supreme Court will rule on the cases now before it, which challenge the 'gag rule" promulgated by your Department in 1988. As you know, that rule forbids Federally funded family planning clinics from providing information about the legal right to abortion services.
I'd like an update on the Department's plans for implementing these regulations, should the Court decide in favor of the Administration and allow the regulations to stand. How much time will Title X providers have to decide whether they will comply with the 1988 regulations?
Answer. If the Supreme Court upholds the regulations, the Department will allow 30 days after the dissolution of any injunction for grantees to provide an assurance of compliance including a description of the manner in which the grantee will provide services in compliance with the regulation. While this may seem a short period, grantees have had 3 years to consider the implications of these regulations, including the matter of whether they will comply and the methods they would use to ensure compliance.
Following receipt of this assurance of compliance, including a description of the manner in which compliance will be effected, grantees will be provided an additional 30 days to come into compliance with the requirements of the rules. In a few cases in which physical or financial entanglements between abortion and family planning are so substantial that a longer period is required to achieve compliance, a longer period may be authorized to achieve compliance with this part of the regulation.
Question. If any Title x providers refuse to comply, does the Department plan to discontinue funding them -- and if so, how will you ensure that Title x services will be continued without interruption?
Answer. We believe that few if any Title X grantees will refuse to participate in the program if the Supreme Court upholds these regulations. However, should any grantees drop out of the program because they decide not to comply with the regulations, there will be little difficulty in transferring the grant to another grantee in an orderly manner.
VACCINE COMPENSATION TRUST FUND
Question. Dr. Mason, you recently told the National Vaccine Advisory Committee that the FY 1992 budget would not include extra funds for the vaccine injury compensation trust fund in order to pay for the cases of injuries and deaths due to vaccines administered before October 1, 1988.
This Committee has provided over $137 million in the past two years to pay these claims. My information indicates that about $47 million remains available. However, over 4,000 claims have been filed, and it may cost up to $3 billion to pay those claims :
These vaccinations are required by the Federal government. Is It appropriate for the government to compensate families of children injured by the vaccinesi
Answer. Yes, it is appropriate for the Federal government to compensate families of children injured by vaccines.
Question. How do you propose to handle this flood of new claims?
Answer. I have asked the Advisory Commission on Childhood Vaccines to develop a set of recommendations to address the financing issues facing the program. I have asked that any potential revisions to the authorizing legislation should be based on scientific knowledge regarding causation of adverse effects related to vaccines.
Question. Dr. Mason, what do recent medical findings indicate about the correlation between injured infants and the vaccines?
Answer. Approximately five to ten cases of vaccine associated poliomyelitis are reported each year. Some of these are contracted by yet undiagnosed immune deficient hosts.
No good evidence exists for MMR (mumps, measles, and rubella) vaccine associated injury. Isolated case reports of suspected but
unconfirmed "postvaccinal encephalomyelopathy" have appeared in the literature.
No characteristic neurologic syndrome or pathology has been found to follow DTP (diphtheria, tetanus, and pertuss18) immunization. Many neurologic illnesses including many of the epilepsies may be present in the first year of 11Ěe and may coincide with time of Immunization. The current literature, however, which includes a number of controlled studies does not allow for a causal association to be drawn between DTP and brain injury, epilepsy, or specifically infantile spa sms. One can conclude then, that if serious neurologic illness occurs following DTP vaccination, it must do so so rarely as to be unmea surable. There are no means at this time by which such an isolated event could be verified. In additions, Sudden Infant Death Syndrome has been studied exhaustively with regard to DTP vaccination, and has not been shown to be caused by this vaccination. A number of benign conditions have been reported, such as the hypotonic hyporesponsive episode--a self limited spell una ssociated with death or permanent sequelae.
Finally, while there is evidence that transient arthralgia and arthritis can in some individuals follow rubella vaccination, it has not been shown that chronic arthritis results.
While anaphylaxis could conceivably occur following any immunization injection, its occurrence in the first year of 11fe is decidedly rare and would not be expected to occur following first exposure to a vaccine.
Question. Will the Administration be seeking legislation to clarify the Federal responsibility to the families of children who were injured or died as a result of vaccinations given before October 1, 19887
Answer. At this point, we have not developed any such legislative proposals.
Question. The budget request for HIV/AIDS information and education activities and preventive services within OASH includes no funds in either FY 91 or FY 92 for preventive services for high-risk persons; no funds for prevention capacity enhancement; no funds for activities targeted to school- or college-aged youth; no funds for education of health care workers and providers; and no funds for activities aimed at the general public. Only special minority initiatives appear to merit funds. Do you believe this budget reflects the national scope of the AIDS problem accurately?
Answer. With the exception of HIV/AIDS activities carried out by the Office of Minority Health (OMH), OASH/HIV responsibilities are limited to policy development, oversight, and coordination of PHSwide HIV/AIDS activities.
Question. Why are no funds requested for any other prevention or education activities in OASH?
Answer. All of the PHS prevention programs other than those funded by OMH, whose focus is on minority AIDS, are operated by the PHS agencies, primarily CDC.
OFFICE OF MINORITY HEALTH
Question. Both the Office of Minority Health and the CDC Office of Minority HIV Policy make grants to national, regional, and community-based organizations serving minority populations; and both
collect data and conduct studies about AIDS in minority groups. How do the activities of these offices differ, and what is the rationale for supporting two separate offices to do the same things?
Answer. The Office of Minority Health HIV/AIDS grants program is different from that of the Centers for Disease Control in that CDC grants target organizations in metropolitan areas with the highest prevalence of AIDS cases, while OMH does not restrict its funding based on the geographic location (urban/rural) of the potential grantee. In fact, OMH tends to fund organizations in areas with a lower incidence of HIV/AIDS. In addition, OMH-funded grants are considerably smaller than CDC's, ranging from $50,000 to $75,000 annually compared to CDC's which range from $20,000 to $225,000 annually. OMH also looks for racial/ethnic diversity in grantees and target populations when making its funding decisions.
Both CDC and OMH maintain ongoing collaboration to ensure that grantees of either agency are not funded to conduct the same activities. This is essential in ensuring that funds are wisely allocated and that a range of community needs are addressed.
As minority HIV/AIDS issues and their impact across geographic areas continue to blend more closely with the missions of OMH and CDC, it is the intent of OMH to merge and/or transfer its national and local HIV grants program with those of CDC.
SEXUAL ACTIVITY AMONG TEENAGERS
Question. Your budget proposes a 54% increase in funds for the Adolescent Family Life program, from $7.8 million to $12 million. This program aims to prevent or reduce sexual activity among teens.
Yet a recent CDC study has shown that more young women than ever are having premarital sex in their mid- to late teens, in spite of their knowledge about the risks of doing so, such as AIDS. The CDC didn't study young men, but it's hard to believe their situation is different.
The Adolescent Family Life demonstration program is 10 years old. Is the program working?
Answer. The Adolescent Family Life (AFL), program is required by statute to expend at least two-thirds of its demonstration funds on projects which demonstrate methods of providing care to pregnant and parenting teens. Thus, less than one-third of the AFL program demonstration funds are permitted by law to be directed toward prevention or reduction of sexual activity among teens.
Teen sexual activity rates are indeed rising. This trend reflects a change in behavioral standards in families, in representations of behavioral norms in the media, and, as a result, changes in the values of teens themselves. It is unrealistic for a program the size of the AFL prevention demonstration component to be expected to reverse the national trend toward increasing sexual activity among teens, and in fact, AFL is not expected to have this effect. Rather, the AFL demonstration program is designed to develop models for families and communities to use in trying to reduce or prevent early sexual activity.
The AFL program has done this. Programs such as Postponing Sexual Involvement in the State of Georgia and the Illinois Commission on the Status of Women's Project Respect, have been supported by AFL: Both demonstrate that in specific communities which dedicate themselves to resolving these issues, the national trends can be slowed or reversed.
There are really only two ways of dealing with the problems of adolescent pregnancy and the teen epidemic of sexually transmitted diseases. Öne is to promote contraception and provide contraceptives