Typical Fraud From Organized Medicine

Discussion in 'Health and medical' started by Jan, Aug 21, 2003.

  1. Jan

    Jan Guest

    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.
     
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  2. WB

    WB Guest

    On 22 Aug 2003 03:15:41 GMT, [email protected] (Jan) wrote:


    <snip>

    >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.


    <snip>

    >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.



    <snip>

    I like the timeliness, er... despise the tiresomeness of the jxdx reports.
     
  3. Anth

    Anth Guest

    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.

    'We assume that our institution is honest.'
    No proofs here - maybe that's why Ralph Moss got fired - for being honest.
    Anth


    "Jan" <[email protected]> wrote in message
    news:[email protected]
    > http://www.iit.edu/departments/csep/perspective/pers1_34dec81_3.html
    >

    [snip]
     
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