FISCAL YEAR 1990 NIH AWARDS TO STATES/TERRITORIES BY DESCENDING Senator COCHRAN. And we will receive, as I understand it, a copy of your report in due course so we can have that before we begin our markup session. Dr. RAUB. Yes; I would hope within a few weeks. Senator COCHRAN. I appreciate that very much, Dr. Raub. Thank you, Mr. Chairman. Dr. RAUB. Thank you, sir. NONTRADITIONAL MEDICAL TREATMENTS Senator HARKIN. Dr. Raub, we have to move along. I just wanted to personally thank you for seeing and spending time with our former colleague, Congressman Berkley Bedell, when he was up to see you recently regarding treatment that he had undergone for prostate cancer I guess. I have been following this. I asked some questions last week of different people in the Department of Health and Human Services, and I propound the same question I will ask Dr. Broder when he is up at the table here about looking at nontraditional approaches toward treating some of the more deadly illnesses and diseases we have in this country such as cancer. I am the first to admit that there are a lot of quacks out there preying on people's emotions, willing to use the emotions that people have to either enrich themselves or to make a quick buck. I understand all that. But I also understand there are people out there that may not be in the traditional mode. They have ingenious ideas and different ways of approaching things. One of the things I am going to be focusing on for the next couple of years or so I am going to be here for at least 6 years. [Laughter.] I am going to focus on a system whereby some of these nontraditional approaches are really looked at in a scientific manner and delved into and not just dismissed. I was looking at an article here that my staff had gotten for me where it said that cancer patients were helped by therapy, a study found, a study done by the OTA on unconventional cancer treatments. It said that psychotherapy had not only improved the quality of the lives but extended the lives of cancer patients. While psychotherapy in cancer treatment was once considered quackery, "the atmosphere has changed," said Mr. Spiegel, a psychiatrist at Stanford University. Here comes Stanford again. [Laughter.] That is sort of the thing I am talking about, to try to look into some of these nontraditional approaches. And I know that you are setting up something to look at this, Doctor. I have never met this guy. I don't know anything about him other than some of the things I have read. And since I have gotten involved in this, I have gotten more incoming fires, you might say, on this doctor's microscope and things like that. Do you have a team that is going to go and look at this up in Canada? Dr. RAUB. We have not completed the arrangements for that yet, but I have had a series of discussions with Mr. Bedell as well as with some potential participants in it. We have sought some information from the Canadian side that we are still waiting for, especially from the equivalent of our FDA, which we think will be helpful to us. Senator HARKIN. Why do you have to do that? Dr. RAUB. Because there has been a major controversy between that particular scientist and the regulatory authorities in Canada, and we would like to understand at least what the differences between them are. Senator HARKIN. Well, that is simple. Go write them and tell them to send you all the information they have on this guy. Dr. RAUB. That is exactly what we are doing. Senator HARKIN. Well, that should not take more than 1 day. Dr. RAUB. We are moving ahead on that. But we did not want to insert ourselves prematurely into another government's regulation. Senator HARKIN. Well, it seems to me Canada is a pretty free country. If you want to go up and talk to a doctor that has some way of treating cancer or has a microscope that he has invented or says that he can do certain things with, I do not see why you really have to go to the government. If you want to get information from the government, that's fine, but I don't know why you need to seek permission. Dr. RAUB. No; we were not seeking permission. It was more to be sure we were fully informed and as a courtesy to Canadian officials. Senator HARKIN. I have no problem with that. Dr. RAUB. But your point is well-taken. NONTRADITIONAL MEDICAL TREATMENTS Senator HARKIN. Again, obviously, there has been some controversy with the Canadian Government with this individual that I have heard about. But I am concerned in short-circuiting all of that and getting people up there to look at it, competent, scientific individuals who can make a judgment on this. Dr. RAUB. The view we have taken with Mr. Bedell is that, while we are paid to be skeptical, we are not paid to be close-minded. So, on this topic and on others in cancer research and in AIDS research, we feel an obligation to identify and try to understand the factual basis, if there is one, on these various claims for treatment. In general, the approach we have taken is to request the data, patient information or other types of data, that would give an independent, objective third party reason to conclude what the advocate concludes. Senator HARKIN. A lot of times in these nontraditional approaches, the data is not cohesive. It is not data that has been pulled together. A lot of it is anecdotal. A lot of it is sparse, and that is why you have to kind of cut through it and go to the source of this and take a look at the source. And that is really what I am requesting that you do in an expeditious a manner as possibleDr. RAUB. Yes, sir. Senator HARKIN [continuing]. With all the competent, scientific individuals you can find to really give it an objective look. QUESTIONS SUBMITTED BY THE SUBCOMMITTEE Thank you very much, Dr. Raub. Thank you all. I am going to have to move to our next panel here for the individuals. Thank you, Dr. Raub. There will be some additional questions from various Senators which we will submit to you for your response. [The following questions were not asked at the hearing, but were submitted to the Institute for response subsequent to the hearing:] QUESTIONS SUBMITTED BY THE SUBCOMMITTEE DIRECTOR'S DISCRETIONARY FUND Question. Last year for the first time the Committee provided the NIH Director with a $20 million discretionary fund. Dr. Raub, I understand that you have made the first allocation out of this fund for the Office of Women's Health, the Office of Minority Affairs, and for a new math-science education program. Please tell us the amounts of each of these allocations and the criteria you have established for use of the discretionary fund. Answer. The FY 1991 Director's discretionary fund will provide $1.5 million to the Office of Research on Women's Health, $1.5 million to the Office of Minority Programs, and $2.0 million for science education. We have solicited from the institutes, centers and divisions their ideas as to what aspects of their programs might be extended or amplified by an allocation from the fund. We will begin to review those soon and develop a set of recommendations for Dr. Healy as to how she may wish to proceed with allocation of the remaining discretionary funds. COST CONTAINMENT Question. Last year both the House and Senate report asked the NIH to develop a cost containment plan to help bring some stability to NIH programs. I understand the plan has the following major elements: Set four year as the average length of research grants. This would help provide funding continuity to investigators while insuring that a sufficient number of competing grants can be made each year. Hold the average cost of increases for research grants to the same rate as the Biomedical Research and Development Price Index. Scrap the practice of "approving" grant applications in favor of the "success rate" method. Fund the maximum number of training grants without Control center costs instead of establishing a limit on the number of centers. Increase funding for other mechanisms to allow for inflation. Tell the Committee a little more about the proposal to scrap the practice of "approving" grant applications. What is the new system that you now propose? Answer. The House and Senate Appropriations Reports both encouraged NIH to modify the peer review system in an effort to address the situation where 95% of applications are approved but only half are really considered as deserving support. To remove the semantic confusion, NIH proposes to abolish the practice of "approving" grant applications. This action would eliminate the category of approved but unfunded applications, i.e., those applications that contribute to the high "approval" rate. In its place, the NIH proposes to adopt the "success" rate. This rate is derived by dividing the number of awards by the total number of applications reviewed, to report funding ratios. This practice is in effect in all other federal agencies. In addition, NIH proposes that Initial Review Groups, as well as Councils and/or Boards not recommend for further consideration any application that does not merit funding under any circumstances. The remaining applications will receive a score as well as a percentile ranking. When the Councils and Boards meet, they will not review the bottom third of these applications. However, any Council or Board may recommend singling out specific applications to be funded from the bottom third on an exceptional basis as a result of scientific and/or programmatic considerations. DELAYED OBLIGATIONS Question. Dr. Raub, $400 million of the $498.1 million increase you have requested is for delayed obligation and will not be available until September 19 with less than two weeks of the fiscal year remaining. I understand that this is a budget gimmick to hold down outlays. We have also had to resort to things like that from time to time up here. Will this proposal cause NIH any operational difficulties? Answer. The FY 1992 Presiden't Budget proposes that $400 million of new budget authority be made available for obligation on September 19, 1992, as part of the effort to insure that government-wide outlay limits are not exceeded. Some minor operational difficulties will be created if the proposal is enacted; awards that normally would be made in late summer 1992 may have to be delayed a month or so. The program consequences, however, should be inconsequential. RESEARCH ON WOMEN'S HEALTH Question. I understand that Dr. Ruth Kirschstein was appointed Acting Associate Director for Research on Women's Health in September. I am glad to see that the office is up and running and the recruitment of a permanent Associate Director is underway. I am also pleased that you used the discretionary fund to provide the office with $1.5 million of research funds. The AIDS I am a little concerned, however, that the operating budget for the office is only $400,000 and 3 positions. coordinating office had 33 people. |