http://www.iit.edu/departments/csep/perspective/pers1_34dec81_3.html NCI Director Interrogated by Senate Committee With the express intent of insuring that federal cancer research money is well spent, Senator Hatch's Committee on Labor and Human Resources held hearings on the National Career Institute's contracting and procurement procedures on June 2, 1981. Although a number of cases of conflict of interest and bookkeeping irregularities were brought to light, the highlight of the meeting consisted of an inquiry into the problem of falsification of research data, with special attention focussed on the case of Dr. Marc J. Straus. The Boston University research team headed by Dr. Straus was, among other things, in effect keeping two sets of records on patients involved in a government funded cancer study. One set was kept for the purpose of having reliable information to serve as a basis for treating patients. The other fictionalized set was kept for the purpose of reporting successful results in the hope of attracting more research grants. When this fraud was revealed in 1978, the NCI did not investigate the matter. Dr. Arthur Upton, who was the director of the NCI at the time, explained his position as follows: "the NCI cannot intervene in the internal affairs of institutions, or pass judgment on individuals, in situations in which we are not directly in volved." Dr. Straus was then able to successfully compete for further research monies from the NCI. Dr. Devito, the current director of the NCI, defended his decision to make this award to Dr. Straus in two ways: First, he argued that Dr. Straus' new grant was not for a clinical study, but rather for more basic research with cell cultures. Second, he pointed out that at the time Dr. Straus had not been proven guilty of any charges of misconduct. When questioned about the case by Senator Hatch, Dr. DeVita replied: "Indeed, Mr. Chairman, at the very least we know this: We know that Dr. Straus was the chairman of a unit where these kinds of infractions took place. He has to bear that kind of responsibility at the very least. At this point in time, he is no longer doing those kinds of things at the Cancer Institute. His current grant is a completely different grant. We, in fact, let it proceed for that particular reason." It was then brought out that Dr. Straus' new grant had originally contained a proposal for some follow-up clinical work, but that this portion of the experiment had been dropped. Senator Hatch then asked why the alleged fraud should not have been a matter of concern in any event: The Chairman. We are aware that the peer review committee did cut that portion of the grant out. However, if you had to do it again, would you not notify them immediately about this problem? Dr. DeVita. Absolutely. There is no question in my own mind, in spite of the Institute's decision not to initiate an investigation-which I again emphasize I did not share in-that any clinical work that involved treating humans would have required an investigation. The Chairman. Dr. DeVita, do you feel that medical ethics, or the alleged lack of medical ethics, should be taken into consideration when Federal funds are applied for, or are being spent on, scientific research situations? Dr. DeVita. Yes, indeed, Mr. Chairman. After this investigation is completed-and we expect it to be completed by mid to late summerthen I believe, if these allegations are true, the system will react accordingly and take these things into consideration. The Chairman. If I understand you correctly, you would presently feel that medical ethics in this case should have been made a factor before further award of funds was made available to Dr. Straws, and that in the future you will make them a factor? Dr. DeVita. Absolutely. The Chairman. Do you think that your conduct in this case will permeate NCI and cause others to be a little more concerned about the use or misuse of Federal funds and the use or misuse of research efforts? Dr. DeVita. I do not believe so, Mr. Chairman. I think we have received a great deal of inquiry about this particular case, a great deal of criticism. Our level of awareness now is very high. We have discussed it many times. It was a matter of judgment at the time. I cannot go back and redo it. Under the circumstances, I could construct a different scenario which I would rather have faced this issue. Had we had a debarment regulation in place, then it would have been quite simple for me to initiate some statement at the board meeting and delay consideration of the grant until the investigation was completed. If the investigation shows that Dr. Straws is guilty of all those charges, all his support in the Institute will be reexamined and reconsidered for continuation. The investigation then turned to Senator Kennedy, the ranking minority member of the Committee: Senator Kennedy. Are there no other ways, or procedures which you think can be devised within the Institute to try and deal with either such a potential or real problem, as the falsification of materials.? Dr. DeVita. Basically when you get dawn to the bottom line, Senator Kennedy, an individual who wants to falsify data entirely in a vacuum can, in fact, falsify data. Our system is based to a large degree on the assumption that the Institution and the individuals have some degree of honesty. However, in our kind of system, as has happened in both the case of Dr. Long and the case of Straws, people do not work in a vacuum. If you produce a scientific result, the first procedure that is followed is to try to reproduce the scientific result. The failure to reproduce that scientific result brings to mind visions of technical problems in the laboratory, but it also raises the question of whether, in fact, someone has falsified the results. In Dr. Longs case, the Institution found the falsification. Dr. Long admitted it. It was quickly handled. I believe there is a built-in mechanism for controlling this sort of thing. It will not ever be perfect, but then again I know of no other system, frankly, at this point in time that will be perfect. Our system of peer review can be referred to the way Winston Churchill referred to democracy: "The worst system invented except for every other system." Senator Kennedy. The most troubling aspect of this is our inability to really know the answer to the following question, and that is whether this is really the tip of the iceberg or is this the iceberg itself? We have had hearings in this committee with, as I mentioned, as many as 31 clinical investigators from different settings involved in the fabrication of data. I think we have to find out how serious a problem this is from a national point of view. Do we know that definitively? Can we say how long it will take to find out? I suppose a reasonable question is to ask whether there are ways and means that we can find out. The FDA has developed a process and procedure to do monitoring, which was a direct result of a series of hearings that we held in this committee.However, I think the question on peoples' minds, with the kinds of allegations and charges we have heard about this morning, is-how many other situations like this are there out across this country? Dr. DeVita. Senator Kennedy, it is my sincere belief that this is a very small problem for the following reasons. This is one of the points that we debate often with the Food and Drug Administration. The organization that Dr. Straws belonged to, the Eastern Cooperative Oncology Group, is a member of one type of cooperative group, of which we have many; 40,000 patients a year are studied under their protocols. There is not any single individual who runs a protocol independent of the other individuals. They each have to submit data separately to the operations office of the group. One immediately has the possibility of contrasting the data from one institution against the other. There is no way one institution can know what another has submitted. Data far out of line with the existing information from other institutions is very likely to be perceived as far out of line and checked at the group meetings by the executive committees. At the encouragement of the Food and Drug Administration, we now have a monitoring contract that does monitoring on early drug studies, that we can turn to, to check data, should we have that kind of suspicion. I think it is rare. Senator Kennedy. The matter that concerns me, with all due respect, is I do not know whether you can say that it really is rare. We had the head of the Food and Drug Administration sitting in that very same seat. When we were looking at research in the FDA, he said that they thought it was rare, until investigators went on out, did a review of a series of their contracts, and found out that it was not so rare. The question is, do we have to rely upon the whistleblowers to raise these kinds of questions with the research? Can there not be some kind of a system that can be established within the NIH, let alone within the Institute? Dr. DeVita. I believe that we do have to depend on the whistleblowers. I, too, am glad that there are people at places like Boston University who find data that does not fit with what it is supposed to be and call it to our attention. I do not know that we will ever be able to do without them entirely. Senators Hatch and Metzenbaum then took Dr. DeVita to task for defending the Institute's decision to make a new award to Dr. Straws on the grounds that he should be regarded as innocent until proven guilty. The Chairman. Doctor, it seems to me you are a little too blase about some of these important things . . . I mean you are not running some hale kiddie game here. You are running a $1 billion a year, very sophisticated, very important, and, hopefully, very successful project. It worries me that you do not understand the difference between how important it is to manage and how important it is to reach the final results. Dr. DeVita. Mr. Chairman, I do not disagree with you one bit. I do not feel blase about these things. These are very important issues.On the other hand, we cannot act until our investigation is complete. The investigation is outside of the Cancer Institute so the Institute itself will not be the main judge. I am waiting far those results. I think we will act expeditiously when we have the is in place. However, I agree with you. Senator Metzenbaum. Would you yield for a minute? The Chairman. Senator Metzenbaum Senator Metzenbaum. I do not quite follow the point that you cannot act until your investigation is completed. The Chairman. I do not, either. Senator Metzenhaum I was thinking about this in relation to private business. Do you think somebody in private business would tolerate a situation and give a new contract for $900,000 to somebody where there is such evidence? You are not in the position of being a jury. You are not running a courtroom. You are the Director of the National Cancer Institute. I do not know why you have to wait for a year or a year and a half for an investigation to be completed. As I gather from what you said, after this investigation is completed, there will then be a committee appointed and there will be a further consideration of matters. Is that right? Dr. DeVita. I believe that will be the procedure, yes. Senator Metzenbaum. I can only say to you, Dr. DeVita, that I have a lot of respect for you as a professional, but, as an administrative leader, I share the chairman's concern about being blase. There are times when it takes some dynamics. It seems tome that in this situation the dynamics are totally absent. What you have permitted to occur is to make a distinction between thefirst contract that involved direct patient treatments and the second contract that involved laboratory work only and to say they are different. That brings to mind that old saying of if you fool me once, you are a fool; if you fool me twice, I am a fool. I think you are putting yourself in a position to be foaled twice with $900,000 of the Federal Government's money . . Somewhere in your mind, you came up with the conclusion that people were entitled to grants unless they were proven guilty. You used the term guilty. It is not a term I would even use. My question to you is how many grants are pending at your shop where there are similar kinds of problems that the Boston Globe has exposed in this instance and that Senator Hatch has referred to in a detailed recitation? What is the responsibility, of the Director of the National Cancer Institute? Do you play a certain kind of judge and jury role, or do you have a responsibility that a private business person would have to move in and say we are not going to do business with this man because there is too much of a grey area, there are too many charges that have been made, and there are too many problems that are existing? What bothers me is you. Dr. Straws does not bother me as much as you do because you knew of these facts, you learned about them, you continued on down the same road, and you are sitting here today saying we are waiting for the investigation to be completed, and, when that is done, we are going to appoint a committee. That is not what private business persons would do if they were spending their own money. They would say they were not going to spend any more money until they find out. It is their job to prove that all these allegations are totally false. Dr. DeVita. I do not know the answer to whether I can, in fact, move in and stop that grant at this point in time. I do not believe it is possible. I am not sure it is correct far me to do that. It is not a matter of my trying to protect an individual. If the individual is guilty, I believe the behavior is absolutely reprehensible and I could not condemn it more. Senator Metzenbaum. However, do you have to find somebody guilty until you say you are not going to give them another grant? That is my question. That is the issue. Dr. DeVita. Again, Senator Metzenbaum, at this point, if that happened, we would delay the funding of a grant. We would have an investigation and we would not fund any grant while the investigation was in process. When Senator Hawkins took her turn, she pursued a different line of questioning. Rather than attacking Dr. DeVita for acting as judge and jury, she turned to the other argument he brought forth in his defense. In essence, Senator Hawkins did not see the presence or absence of clinical studies as relevant to the question as to whether or not Dr. Straws was entitled to federal research dollars. Senator Hawkins. We are talking to scientists about scientific data. It is either true or false. Yet I am sure that if we have the court reporter read back your answer to one of the first questions that we have all referred to-Senator Kennedy, Senator Metzenbaum, Senator Hatch, and myself-I wrote down in disbelief that you said you felt it was all right to give Dr. Straus the second award-almost $1 million. I know that is not much to you when you are dealing with hundreds of millions. But, I think as you stated, although he was alleged to be dishonest in clinical work, he would not be dishonest in basic research. Are you telling me that scientists have situation ethics? Dr. DeVita. No, Senator Hawkins, I am not. Senator Hawkins. You are either honest or you are dishonest. Dr. DeVita. I think the issue at hand was patient safety in the sense that we would not, even in the case where the allegations against an investigator had not been proven, allow any clinical therapeutic research to proceed because that matter would require an investigation. Senator Hawkins. Let us follow that further. You now have him in a laboratory somewhere, doing experiments, and the deductions, data, and knowledge which is gained from those experiments may be translated into recommended therapy to human beings, as I understand it. If you look at the information that has been given you on some of the cases we all have seen and that Senator Hatch referred to, we are talking about one patient whose white blood cell counts were changed. That is dishonest. We are talking about a human being and his treatment. Is it logical, or, in your mind, is it completely different in a test tube environment with just test tubes? Is he not going to change his results in the test tube environment as he allegedly did in his clinical work with human beings? Dr. DeVita. That is certainly possible, Senator Hawkins. Senator Hawkins. You are saying those are allegations and, until it was proven, you felt that he was innocent, and that I am safe from him, if you put him in a laboratory, close the door, and let him conduct $919,000 worth of experiments, the results of which may be translated into applications to this same patient.