Typical Fraud From Organized Medicine



J

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.
 
W

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.
 
A

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]