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Visual impairment due to cataracts in the aging eye

Diagnosis and treatment of benign prostatic hyperplasia

Pain Management

Diagnosis and treatment of depressed outpatients in primary
care settings

Delivery of comprehensive care in sickle cell disease

Prediction, prevention, and early treatment of pressure sores in adults

Urinary incontinence in the adult

In addition, in FY 1991 the AHCPR will constitute a panel on HIV clinical guideline development.

Program Support:

The FY 1992 budget request includes $2,330,000 for Program Support. This request will support the overall direction and management of the Agency for Health Care Policy and Research. This includes the formulation of policies and program objectives for the Agency; program planning and evaluation; grants and contracts management; resource management; and administrative management and services activities.

Mr. Chairman and Members of the Committee, I will be pleased to answer any questions you may have on the specifics of this budget request.


Senator HARKIN. Dr. Clinton, I have really two questions that I want to discuss with you, and then the rest we will submit for the record.

First, on the medical treatment effectiveness, the outcomes research level funding from last year, is this adequate to really keep up with the medical treatment effectiveness research? We have had a couple of years of big increases, and now it has leveled off. Why have we leveled that off? Why has your request leveled off there?

Dr. CLINTON. I think the constrained resources for all of us requires us to make several difficult decisions. While the Medical Treatment Effectiveness Program was certainly part of the energy and creation of the new agency, we became concerned that it was overshadowing the important fundamental health systems and health services research that is also under the jurisdiction of the Agency for Health Care Policy and Research.

Our primary objective this year in presenting a budget within those constraints was to bring a rebalance to the general health services research program. That had to be at some expense within our total agency budget, and we chose then to raise general health services research, holding the Medical Treatment Effectiveness Program at approximately last year's level.

I think the magnitude of work underway can without any question be sustained with that level of funding. It will make it not as vigorous in growth as it was in the first year, but that is to be understood. We are trying to accomplish a balanced program within the agency rather than focus on simply one component of the agency's required work.


Senator HARKIN. Second and last question, you talked about investigating and researching alternate methods and means of medical delivery services, using different methods of delivering services. Let me ask you a more fundamental question.

When are we going to investigate nontraditional methods of medical treatment? You have a big budget here for $122 million, of which the total for health services, research, and technology assessment is $56.7 million.

What are we doing? Are you doing anything to investigate nontraditional medical treatments?

Dr. CLINTON. Could you give an example of what you mean by nontraditional health care?

Senator HARKIN. Sure. Different forms of treating cancer, for example; different methods for Lyme disease is another one. I am thinking back many years ago when acupuncture was looked upon as voodoo medicine, and we found out it actually worked. I think it is, if not widely, at least somewhat widely used in the United States and other countries around the world.

There are many reports from different areas that I have read. People have talked to me about how they have taken a different approach to perhaps curing Lyme disease or cancer or other things. They have said that it works. I find that there seems to be a reticence on the part of the medical community to not only accept but to at least objectively look at these. It is sort of considered, well, quackery. The medical community treats cancer this way, and that way is quackery.

I am wondering if you are looking at some of these. I mean you know as well as I do that there are a lot of different approaches that people are taking.

Dr. CLINTON. I understand what you mean now.

Senator HARKIN. I read a book a couple of years ago about an individual in Pennsylvania who had cancer who was told he had not much of a chance and decided to take matters into his own hands. He was not a doctor, but he was involved in health care. He decided to treat it differently. His was a completely different approach, and yet he is alive and well today and cured of cancer.

What is being done to really look into these to see if there is anything there rather than just dismissing it as a quirk, something that is unexplainable and that type of thing?

Dr. CLINTON. There are two aspects to that, Mr. Chairman. First of all, any investigator in the United States who wants to propose a scientific study about what works in medicine can submit that application to the Public Health Service. That is translated predominantly to the grants receival system of the National Institutes of Health.

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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:]



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.

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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. To
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.

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