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Our proposals all go to that same institution in which they are divided up and sent to us if they deal with health systems issues and they go to NIH Institutes if it is more appropriate to the work under their jurisdiction.

The issue of efficacy which is what you are talking about-would an alternative plant-derived substance or would an alternative treatment provided by a certain kind of practitioner work betteris generally the work that NIH undertakes. They look at the efficacy of a particular treatment. Does it work under a controlled environment?

It is only after it has been identified that there is a reasonable science of efficacy in the controlled environment that we look among all the different options of what works best in the environment of America in general. What works best in rural health hospitals? What works best in urban centers? What works best for the general practitioners, for specialized practitioners? What works best with regard to certain technologies?

So, it is unlikely that the proposal that you describe would be sent our way unless they had called us and talked about it.

We have tried to keep an open eye to groups who allege that they have not been given fair access to Public Health Service grants; chiropractic is an example. We have worked hard to get chiropractic involved with our low back pain activity and with other places where they might make a contribution.

We have worked hard to be sure that allied health is more appropriately involved in both outcomes research and guideline work. These are groups that certainly are not nontraditional. They are licensed to practice in these United States, but we think that they have been excluded from even looking at what works best within what is already known to be efficacious.

No; we have not received proposals nor talked with anyone about herbalists, holistic medicine, and many of the nontraditional issues you talk about.


Senator HARKIN. Do you think these alternative proposals will get a fair hearing?

Dr. CLINTON. I think they probably lack scientific_soundness in their approach. If they would work with the scientific community to insure that their epidemiology and biostatistics are correct, they would probably have a greater chance of a reasonable score and, therefore, an award.

I am sure that there are biases against them. That would be a difficult challenge. I think we would have to gather a number of them together, think through what they are trying to propose, look at the scientific merits of it, and the way they are going to examine the question.

If the scientific approach in examining the question is flawed, then there is no purpose in investigating it further. I think that would be the fundamental requirement required of a study section either at NIH or a study section under our jurisdiction.

If there were a group that wanted to pursue that, we would be delighted to do so. As you know and as your staff are aware, we have worked hard at providing technical assistance to groups that

do not have much experience in submitting grants and proposals to the Public Health Service. If you believe it is warranted and there is a group that would like to talk about it, we would certainly welcome them.

Senator HARKIN. I might follow up with you outside of the hearing room here to see how we might do this.

Dr. CLINTON. That would be fine. We should talk about it.

Senator HARKIN. I am interested in finding out some way of moving ahead in that direction, again just to give them a fair hearing and see what the scientific basis is and see if we can set up structures by which we can

Dr. CLINTON. I think they deserve to have it.

Senator HARKIN. To see whether or not it is logical. I do not know.

Dr. CLINTON. We will be pleased to respond.


Senator HARKIN. I will follow up. We will talk about this later


Dr. Clinton, thank you very much for being here and for your testimony. We have some questions for the record, but in the interest of time we will have to submit those in writing.

Dr. CLINTON. Fine. Thank you.

Senator HARKIN. Thank you.

[The following questions were not asked at the hearing, but were submitted to the Department for response subsequent to the hearing:]

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Question. Dr. Clinton, you and your agency should be commended for your efforts to make the research you conduct relevant to a lot of people who have been neglected too often in this area. Your work with rural and minority providers and populations is very important.

it's a

There's one other group I want to ask you about big group: women. NIH and ADAMHA have come under fire recently because so much of their research is neither conducted by or about women. Billions of dollars later, we have a serious gender gap in our research base.

How is AHCPR addressing this situation?

Answer. In FY 1990, 44% of the new grants funded by the Agency for Health Care Policy and Research (AHCPR) were awarded to female principal investigators. We expect this trend to continue

in FY 1991 and FY 1992.

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Currently, the AHCPR has several activities underway designed to address the gender gap in our research base:

We will require through regulations and our grant
announcements that research proposals must, as appropriate,
include women in their study populations and address
variances in outcomes by gender. This is consistent with
the policies adopted by NIH and ADAMHA. For example,
research dealing with cardiovascular diseases would be
expected to have adequate numbers of females in the study
design; on the other hand, research on prostate cancer would

Several recently-funded large-scale Patient Outcome Research Team (PORT) projects address issues of particular concern to women. One is examining childbirth issues, including decisions regarding the use of cesarean sections, and another is examining the treatment of gallbladder disease, a major health problem in older women. A third PORT is studying hip fracture repair and osteoarthritis.

AHCPR is actively involved in the Secretary's Action Plan on Women's Health. Specifically, AHCPR is committed to the following goals included in that plan:

Ensuring that AHCPR's program of health services

research addresses major issues in women's health. Το
achieve this goal, the Agency will compile an
inventory of all current research addressing how women
are covered in that research, and include a discussion
of the PHS policy on the inclusion of women in
research studies in all new program solicitations and
grant materials.

Conducting research to improve the access to care and quality of care provided to women with AIDS/HIVrelated illnesses. Women will be included in a major AHCPR survey examining health care services utilization, financing, barriers to care, functional status, and quality of care.

Supporting the development and dissemination of
clinical guidelines for HIV infection that are
sensitive to the unique needs of women.

Funding research intended to improve access to health services among minority and low-income women and women with disabilities. Currently, AHCPR is developing plans for the third National Medical Expenditures Survey (NMES) that will provide extensive data on the health care needs of these women. In addition, AHCPR will fund investigator-initiated and targeted extramural research in this area.


Question. The cost per case for treating AIDS victims appears to vary enormously from one locality to another. Given that this epidemic is spreading rapidly among certain populations, and we can expect treatment costs to rise accordingly, I'd like to know about AHCPR's work in this area.

What can you tell us about preventive measures and effective, lower-cost treatments for AIDS are there methods being used in San Francisco, for example, that the people in Jersey City ought to know about?

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Answer. Across most studies, the lifetime cost of treating AIDS among adults ranges from $40,000 to $90,000. Various factors account for these differences, ranging from regional variations in expertise and availability of formal and informal community-based options, to population differences in severity of illness and barriers to care, the use of costly pharmaceuticals to treat existing complications of HIV, and the availability of primary and secondary prophylactic treatment against opportunistic infections that ward off expensive hospitalizations.

Earlier research frequently found lower medical care costs on the West Coast, due largely to expertise in managing the illness and the availability of more efficient outpatient community-based options for care. However, current findings are pointing to a narrowing of these differences perhaps due to the widespread use of expensive pharmaceutical interventions by homosexual/bisexual men on the West Coast, which may not be as readily available to other risk groups largely concentrated on the East Coast.

As part of its AIDS Medical Care Effectiveness Program, the AHCPR is conducting the AIDS Cost and Service Utilization Survey (ACSUS). This survey will collect longitudinal, prospective patient interview data, as well as medical and billing record

data, from 2,000 HIV patients recruited across more than 20 provider sites in 10 urban regions for a period of 18 months. A separate sample of 400 children also will be followed.

The survey is being fielded at the end of March 1991 and preliminary results addressing some of the medical care resource utilization issues noted above will be available by the beginning of 1992. In addition, several other investigator-initiated largescale studies of resource utilization are underway which will provide detailed information on factors influencing population differences in the cost of medical care for HIV.

Question. Tell us about your agency's development of clinical practice guidelines for AIDS treatment, and how the information will be disseminated to providers.

Answer. The Agency for Health Care Policy and Research (AHCPR) has initiated a project to develop clinical practice guidelines for HIV/AIDS. These guidelines will be developed by a panel of clinical experts and health care consumers for use by physicians, educators, and other health care practitioners to assist in determining how HIV-related diseases, disorders, and other health conditions can most effectively and appropriately be diagnosed, treated, and managed clinically. A panel chair and cochair have been appointed and will meet at the end of March to select the remaining members of the panel from all nominations received. Also, at least two subpanels will be constituted; one which will focus on pediatric HIV and one on women with HIV. first meeting of the main panel will take place in June 1991.


As the initial set of clinical practice guidelines are completed, AHCPR will promote and support their dissemination to practitioners and other users, beginning in the Fall 1992. Organizations of health care practitioners, health care consumers, peer review organizations, accrediting bodies, academic medical centers, medical educators, researchers, payers, and other appropriate groups will be encouraged and energized to disseminate the guidelines to their members and constituents. These promotional efforts will be facilitated by presenting the guidelines in print, through other media, and in formats that readily can be understood and implemented by various users. Guidelines will be made available through medical libraries and indexing services including the National Library of Medicine and its outreach systems. It is anticipated that continual updating of the guidelines will take place. Also, AHCPR will evaluate the success of its dissemination efforts, including the effects on clinical practice and patient outcomes.


Question. I understand that AHCPR may be doing work in the future on breast cancer. This is an area of particular interest as the sponsor of legislation expanding Medicare coverage of breast cancer screening. Just two weeks ago, I introduced a bill to expand that coverage to women ages 50 64.

to me,

What would a MEDTEP study of breast cancer actually study: would the research investigate only treatments, or is it

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